DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue
Document Control Center - WO66-G609
Silver Spring, MD 20993-0002

June 20, 2016

RAY Co., Ltd.
c/o Jeff Rongero, Staff Engineer
UL LLC
12 LABORATORY DRIVE
RESEARCH TRIANGLE PARK, NC 27709

Re: K160525
Trade/Device Name: RCT700
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed Tomography X-Ray System
Regulatory Class: Class II
Product Code: OAS
Dated: May 6, 2016
Received: May 10, 2016

Dear Jeff Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability
warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
it may be subject to additional controls. Existing major regulations affecting your device can be
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must comply
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product
radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Page 2 - Jeff Rongero

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the
Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs, Ph.D.

Director
Division of Radiological Health
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: January 31, 2017
Indications for Use See PRA Statement below.

510(k) Number (if known)

K160525

Device Name
RCT700

Indications for Use (Describe)

CBCT, panoramic x-ray imaging system with cephalostat, is an extra oral source x-ray system, which is intended for
dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and
implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate
dental maxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the
examined volume image is reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard
narrow beam technique.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 510(k) Submission- RCT700

510(k) Summary

The summary of 510(k) safety and effectiveness information is being submitted in accordance with the
requirements of 21 CFR Part 807.92.

Date: December 30, 2015

APPLICANT RAY Co.,Ltd

ADDRESS #332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823, Korea

Manufacturer RAY Co.,Ltd

332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823, Korea

TEL : +82-31-605-1000
FAX : +82-2-6280-5534

Contact Person Changhwan Lee

e-mail : ch0406.lee@raymedical.co.kr

Device Name

Trade/Proprietary Name: RCT700

Common Name: Dental panoramic/tomography and cephalometric x-ray system

Classification

Classification Name: Computed tomography x-ray system (21 CFR 892.1750)

Class : II
Product code : OAS
Panel : Radiology

Predicate device

Parameter Predicated Device-1 Predicated Device-2

Device Name RAYSCAN α–Expert3D RAYSCAN α–Expert3D

Manufacturer RAY Co., Ltd RAY Co., Ltd

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 510(k) Submission- RCT700

K122981 K142247
510(K) Number
Traditional 510k Traditional 510k
Computed tomography x-ray Computed tomography x-ray
Classification name
system system

Regulation number 892.1750 892.1750

Primary product code OAS OAS

Description

System purpose RCT700 is 3D computed tomography for scanning hard tissues like bone and teeth. By
rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on
each end, CBCT images of dental maxillofacial is attained by recombining data from the same level that
are scanned from different angle.
Panoramic image scanning function for attaining image of whole teeth, and cephalometric scanning
option for attaining cephalometric image are included. RCT700 options combination are as shown in the
table below.

Indication for use

CBCT, panoramic x-ray imaging system with cephalostat, is an extra oral source x-ray system, which is
intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for
panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the
capability, using the CBVT technique, to generate dental maxillofacial 3D images. The device uses cone
shaped x-ray beam projected on to a flat panel detector, and the examined volume image is
reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard narrow beam
technique

“CAUTION: Federal law restricts this device to sale by or on the order of a dentist.”

Patient population

The patient population can be the possible person who can be taken X-ray diagnostic radiation exposure.
There is no restriction for ethnic group, Gender, weight, health, or condition.
We recommend patients for x-ray diagnostic radiation exposure to be over 5 years old.

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 510(k) Submission- RCT700

Device functions

The purpose of this unit is diagnose clinical structures of a tooth and head areas mainly by using the
characteristics of permeability from X-ray. The principle of functioning and formations are as following.
The machine is made of X-ray generator and arms in which transfers X-ray signals to a sensor in 2D. Also,
an object that has a magnification is required in a distance. Moreover, the unit has to be adjustable
depending on height of a patient and PC system to reconstruct an image.
The arm parts are controlled for rotating and linear moving to synchronize between the sensor and X-ray
generator to get the image of interests. The purpose of this mechanism is to provide the images in 2D
or/and 3D as preferred to diagnose in a monitor. CBCT provides in 3D images as reconstructed and
Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic
treatment. These 3 functions could be in 1 system, Panorama with Cephalometric, or Panorama only
system depending on the needs. To provide the features as mentioned above, digital transferring from
permeated X-ray to absorbing to the sensor is essential and all the process are proceed in Detector.
Detector transfers X-ray to light depending on the structure materials. Detector is separated into indirect
method that the light is changed to digital signals on photodiode and direct method in which the light is
directly transferred to digital signal. This unit is using both direct and indirect method depending on the
interior structure materials.

Operating principle of the detector

X-ray data entered into the detector from an outside source is converted to visible ray by detector’s
Scintillator and the visible ray is transferred to CMOS ASIC and converted to an Electric signal to form an
image signal.
Then the signal is changed to a Digital form and through the high speed LAN cable, the acquired image
data is transmitted to the PC.
Acquired resulting image is displayed on the monitor by the PC Software.

Detector Options

RCT700 detector, depending on the modality, consists of SIX 650HD-E (Manufacturer: THALES) in case
of the CT and one of three detectors in case of PANO, C10500D-43 (Manufacturer: Hamamatsu), XID-
C15DP (Manufacturer: i3System) or SIX 650HD-E (Manufacturer: THALES).

Ceph is categorized by Scan Ceph or One shot Ceph according to the imaging methodology and the
detector implemented in RCT700 Scan ceph is the XID-C24DS (Manufacturer: i3system) model whereas
the detector used in the One shot Ceph is PaxScan 4336X (Manufacturer: Varian medical systems) and
PaxScan 2530C (Manufacturer: Varian medical systems).

In particular, the detector used in SIX 650HD-E may also be used as a detector for PANO.
Meaning the SIX 650HD-E detector is capable of being used as an independent detector in CT or the
PANO modality or in CT and PANO Modality simultaneously.

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 510(k) Submission- RCT700

RCT700 options combinations are as shown in the table below.

Device Designation

Division Description
CT(SIX 650HD-E) + Pano(C10500D-43)
CT + Pano
CT(SIX 650HD-E) + Pano(XID-C15DP)
CT(SIX 650HD-E) + Pano(C10500D-43) + Scan Ceph(XID-C24DS)
CT + Pano + Scan Ceph
CT(SIX 650HD-E) + Pano(XID-C15DP) + Scan Ceph(XID-C24DS)

CT(SIX 650HD-E) + Pano(C10500D-43) + One shot Ceph(PaxScan 4336X)

CT + Pano + One shot Ceph(L)
CT(SIX 650HD-E) + Pano(XID-C15DP) + One shot Ceph(PaxScan 4336X)

CT(SIX 650HD-E) + Pano(C10500D-43) + One shot Ceph(PaxScan 2530C)

RCT700

CT + Pano + One shot Ceph(S)

CT(SIX 650HD-E) + Pano(XID-C15DP) + One shot Ceph(PaxScan 2530C)

CT CT(SIX 650HD-E)

CT + Scan Ceph CT(SIX 650HD-E) + Scan Ceph(XID-C24DS)

CT + One shot Ceph(L) CT(SIX 650HD-E) + One shot Ceph(PaxScan 4336X)

CT + One shot Ceph(S) CT(SIX 650HD-E) + One shot Ceph(PaxScan 2530C)

CT,Pano CT,Pano(SIX 650HD-E)

CT,Pano + Scan Ceph CT,Pano(SIX 650HD-E) + Scan Ceph(XID-C24DS)

CT,Pano + One shot Ceph(L) CT,Pano(SIX 650HD-E) + One shot Ceph(PaxScan 4336X)

CT,Pano + One shot Ceph(S) CT,Pano(SIX 650HD-E) + One shot Ceph(PaxScan 2530C)
Remark
*Pano: C10500D-43(Hamamatsu)
*Pano: XID-C15DP(i3System)
*CT: SIX 650HD-E(THALES)
*Scan Ceph: XID-C24DS(i3system)
*One shot Ceph(S): PaxScan 2530C(Varian medical systems)
*One shot Ceph(L): PaxScan 4336X(Varian medical systems

Comparison with predicate device

Similarities:

The proposed device has the same intended for use and technical characteristic as the predicate device.
A comparative analysis indicates that the following categories are similar: the mode of operation, 3D
technology, performance specification, main features [such as X-ray tube, High voltage generator, CT
detector, PANO detector and CEPH (Scan type, one-shot type) detector], Collimator operation type (Auto),

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 510(k) Submission- RCT700

Class I with type B applied parts according to IEC 60601-1, focal size, DICOM 3.0 format compatible,
network method, type of installation, and applicable standards. (See Table 1 for compares the
characteristics between the predicate device)

Differences:

In case of RCT700, detector implemented in the device varies according to its modality; CT, PANO, Ceph
and the corresponding detectors are described below.
In case of CT, Predicate devices RAYSCAN α–Expert 3D[K122981, Traditional] and RAYSCAN α-
Expert3D[K142247, Traditional] included the C10900D model, however the Proposed device RCT700
includes the SIX 650HD-E model detector.

In case of PANO, Predicate devices RAYSCAN α–Expert 3D[K122981, Traditional] and RAYSCAN α-
Expert3D[K142247, Traditional] uses the C10500D model whereas the Proposed device RCT700 is
capable of incorporating one of 3 types of detector models; C10500D, SIX 650HD-E or XID-C15DP.

Cephalometry is classified into Scan type or the One shot type depending on the imaging method and in
case of the Scan type, Predicate device included the XID-C24DS detector which is an equivalent model
to that of RAYSCAN α-Expert3D[K142247, Traditional].
In the One shot type, Predicate devices RAYSCAN α–Expert 3D[K122981, Traditional] included the SDX-
4336CP model detector whereas RAYSCAN α-Expert3D[K142247, Traditional] and the Proposed device
is capable of handling both the PaxScan 4336X and PaxScan 2530C detector models.
These 2 types of detectors are identical in technical characteristics, method and manufacturer and the
only mentionable difference is that PaxScan 4336X detector is 42.4 (V) cm x 35.3 (H) cm in size and
PaxScan 2530C detector is 24.9(V)cm x 30.2(H)cm.
Hereafter, the PaxScan 4336X mounted in the proposed device RCT700 One shot type will be referred to
as Large size and PaxScan 2530C detector as the standard size.

Following is the comparison table listing the type of modality detectors mounted in Predicate devices
RAYSCAN α–Expert 3D[K122981, Traditional] and RAYSCAN α-Expert3D[K142247, Traditional] and the
optional detector types mounted in the proposed device RCT700.

Proposed Device Predicate Device #1 Predicate Device #2

Division RCT700 RAYSCAN α–Expert3D RAYSCAN α–Expert3D

K160525, K122981, K142247,

Traditional Traditional Traditional

Manufacturer Thales Hamamatsu

Model SiX 650HD-E C10900D
Scintillator
CsI (Indirect type) CsI (Indirect type) Same as predicate
CT Material
device #1
Total pixel area 144.0(W)x117.9(H)mm 124.8(W)x124.8(H)mm
Total pixel 960x786 624x624
Pixel size 150um 200um

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 510(k) Submission- RCT700

Limiting
3.3lp/mm 2.5lp/mm
resolution
Power
5VDC / 7.5W 5VDC / 1250mA
supply/Main
MTF 60% at 1LP/mm 58% at 1LP/mm
DQE 0.45 at 1LP/mm 0.22 at 1LP/mm

VOXEL 0.07~0.4mm 0.28mm

Manufacturer Hamamatsu
Model C10500D
Scintillator
CsI (Indirect type)
Material
Total pixel area 6.0(W)x1512(H)mm
Total pixel Same as predicate 60x1512 Same as predicate
PANO-1
Pixel size device #1 100um device #1

Limiting
5.0lp/mm
resolution
Power
5VDC / 1100mA
supply/Main
MTF 70% at 1LP/mm
DQE 0.5 at 1LP/mm
Manufacturer Thales
Model SiX 650HD-E
Scintillator
CsI (Indirect type)
Material
Total pixel area 144.0(W)x117.9(H)mm
Total pixel 960x786
PANO-2 N/A N/A
Pixel size 150um
Limiting
3.3lp/mm
resolution
Power
5VDC / 7.5W
supply/Main
MTF 60% at 1LP/mm
DQE 0.45 at 1LP/mm
Manufacturer i3System
Model XID-C15DP
Scintillator
CdTe(Direct type)
PANO-3 Material N/A N/A
Total pixel area 4.8(W)x150(H)mm
Total pixel 48x1500
Pixel size 100um

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 510(k) Submission- RCT700

Limiting
5.0lp/mm
resolution
Power
5VDC / 2A
supply/Main
MTF 75% at 1LP/mm
DQE 0.88 at 1LP/mm
Manufacturer i3System
Model XID-C24DS
Scintillator
CdTe (Direct type)
Material
Total pixel area 4.8(W)x240(H)mm
Ceph Same as predicate
Total pixel 48x2400
(scan N/A
type) Pixel size device #2 100um
Limiting
5.0lp/mm
resolution
Power
5VDC / 2A
supply/Main
MTF 75% at 1LP/mm
DQE 0.88 at 1LP/mm
Manufacturer Samsung Mobile Display Varian
Model SDX-4336CP PaxScan 4336X
Scintillator
SDX-4336CP GADOX (Indirect type)
Material
Ceph Total pixel area 43.2 x 36.0 cm 427(W)x356(H)mm
(One
shot )-1, Total pixel Same as predicate 2880 x 2400 3072x2560
Pixel size device #2 150 um 139um
Large
Size Limiting
3.3 lp/mm 3.6lp/mm
resolution
Power
100-240VAC, 50/60Hz 100-240VAC, 47-63Hz
supply/Main
MTF 45% at 1LP/mm 54% at 1LP/mm
DQE 0.41 at 1P/mm 0.2 at 1LP/mm
Manufacturer Varian
Model PaxScan 2530C

Ceph Scintillator
(One GADOX (Indirect type)
Material Same as predicate
shot)-2,
N/A
Total pixel area device #2 302(W)x249(H)mm
Standard
Size Total pixel 2176x1792
Pixel size 139um
Limiting
3.6lp/mm
resolution

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 510(k) Submission- RCT700

Power
100-240VAC, 47-63Hz
supply/Main
MTF 54% at 1LP/mm
DQE 0.2 at 1LP/mm

Information for detector own 510(K) number or system in which it was cleared 510(k) number.

Own 510(K) System in which it was cleared

Division Model Manufacturer
number 510(k) number.

1) System name: Unknown

CT SiX 650HD-E Thales No 2) Manufacturer: Unknown
3) 510(K) Number: Unknown

1) System name: RAYSCAN α–Expert3D

Pano-1 C10500D Hamamatsu No 2) Manufacturer: RAY CO., LTD
3) 510(K) Number: K122981

1) System name: Unknown

Pano-2 SiX 650HD-E Thales No 2) Manufacturer: Unknown
3) 510(K) Number: Unknown

1) System name: PAPAYA plus

Pano-3 XID-C15DP i3System No 2) Manufacturer: Genoray
3) 510(K) Number: K130419

1) System name: RAYSCAN α–Expert3D

Scan Ceph XID-C24DS i3System No 2) Manufacturer: RAY CO., LTD
3) 510(K) Number: K131695

1) System name: RAYSCAN α–Expert3D

PaxScan
One shot Ceph Varian No 2) Manufacturer: RAY CO., LTD
4336X
3) 510(K) Number: K142247

1) System name: RAYSCAN α–Expert3D

PaxScan
One shot Ceph Varian No 2) Manufacturer: RAY CO., LTD
2530C
3) 510(K) Number: K142247

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 510(k) Submission- RCT700

Statement of Substantial Equivalence

Parameter Proposed Device Predicated Device Predicated Device

Manufacturer RAY Co., Ltd. RAY Co., Ltd. RAY Co., Ltd.
Device name RCT700 RAYSCAN α–Expert3D RAYSCANα–Expert3D

K160525 K122981 K142247

510(K) Number
(Traditional 510K) (Traditional 510K) (Traditional 510K)

Common Dental panoramic/tomography and Dental panoramic/tomography and Dental panoramic/tomography and
Name cephalometric x-ray system cephalometric x-ray system cephalometric x-ray system
RCT700, panoramic x-ray imaging RAYSCAN α–Expert 3D, panoramic x- RAYSCAN α–Expert 3D panoramic x-
system with cephalostat, is an extraoral ray imaging system with cephalostat, is ray imaging system with cephalostat, is
source x-ray system, which is intended an extraoral source x-ray system, which an extraoral source x-ray system, which
for dental radiographic examination of is intended for dental radiographic is intended for dental radiographic
the teeth, jaw, and oral structures, examination of the teeth, jaw, and oral examination of the teeth, jaw, and oral
specifically for panoramic examinations structures, specifically for panoramic structures, specifically for panoramic
and implantology and for TMJ studies examinations and implantology and for examinations and implantology and for
and cephalometry, and it has the TMJ studies and cephalometry, and it TMJ studies and cephalometry, and it
Indications capability, using the CBVT technique, to has the capability, using the CBVT has the capability, using the CBVT
for use generate dento-maxillo-facial 3D technique, to generate dento-maxillo- technique, to generate dento-maxillo-
images. facial 3D images. facial 3D images.
The device uses cone shaped x-ray The device uses cone shaped x-ray The device uses cone shaped x-ray
beam projected on to a flat panel beam projected on to a flat panel beam projected on to a flat panel
detector, and the examined volume detector, and the examined volume detector, and the examined volume
image is reconstructed to be viewed in image is reconstructed to be viewed in image is reconstructed to be viewed in
3D viewing stations. 2D Images are 3D viewing stations. 2D Images are 3D viewing stations. 2D Images are
obtained using the standard narrow obtained using the standard narrow obtained using the standard narrow
beam technique. beam technique. beam technique.
Continuous operation with Continuous operation with Continuous operation with
Mode of
intermittent, stated permissible intermittent, stated permissible intermittent, stated permissible
Operation
loading loading loading
CBCT Cone beam
CBCT Cone beam CBCT Cone beam
3D technology Computed Tomography
Computed Tomography Computed Tomography

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 510(k) Submission- RCT700

1) CBCT Computed tomography 1) CBCT Computed tomography 1) CBCT Computed tomography

2) Panoramic 2) Panoramic 2) Panoramic
Performance
3) Cephalometric(optional) 3) Cephalometric(optional) 3) Cephalometric(optional)
Specification
- One shot type - One shot type - One shot type
- Scan type - Scan type
Base
RAYSCAN α-3D :
CT+PANO

Base Option(CEPH)
RAYSCAN α-3D : RAYSCAN α-SM3D:
CT+PANO CT + PANO + SCAN CEPH
Functional
Refer to Device Designation table in
Option
description section of 510K summary. Option(CEPH) RAYSCAN α-M3DS:
RAYSCAN α-Multi 3D: CT + PANO + One shot(9.8 X 11.9
CT + PANO + One shot inch)

RAYSCAN α-M3DL:
CT + PANO + One shot(16.8 X 14.0
inch)
Jaw(Standard)
Jaw-Fast Jaw(Standard)
Standard
Surgical guide Surgical guide
Surgical guide
Facial Implant surgery
Implant surgery
CT Teeth Endo treatment
Endo treatment
Endodontics TMJ
TMJ
TMJ Sinus
Exam Sinus
Sinus
Mode
Airway
Standard(Normal) Standard(Normal)
TMJ Normal(Adult) TMJ
Sinus Pedodontics(Children) Sinus
PANO
Segmentation (Individual Tooth) TMJ Segmentation (Individual Tooth)
Bitewing Sinus Bitewing
Orthogonal Orthogonal

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 510(k) Submission- RCT700

Posterior/Anterior Posterior/Anterior
PA,AP
Lateral Lateral
Lateral
SMV SMV
Ceph SMV
Carpus Carpus
(Optional) Carpus
Reverse Town’s Reverse Town’s
Reverse Town’s
Waters Waters
Waters
Lateral wide Lateral wide
CT SiX 650HD-E C10900D C10900D

C10500D C10500D C10500D

PANO SiX 650HD-E

Detector
XID-C15DP
Type
Ceph (Scan) XID-C24DS XID-C24DS

PaxScan 4336X SDX-4336CP PaxScan 4336X

Ceph (One shot)
PaxScan 2530C PaxScan 2530C

Exposure switch
“Deadman” Button type Deadman” Button type “Deadman” Button type
Type
Ceph Apparatus Ceph Apparatus Ceph Apparatus

Vertical Carriage Vertical Carriage Vertical Carriage

Rotator Rotator Rotator

Main
X-RAY Generator X-RAY Generator X-RAY Generator
Components
X-ray tube X-ray tube X-ray tube

High Frequency Generator High Frequency Generator High Frequency Generator

Column Column Column

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 510(k) Submission- RCT700

Touch monitor (panel) Touch monitor (panel) Touch monitor (panel)

Detector
- CT Detector
SiX 650HD-E Detector - CT
- CT C10900D
- PANO C10900D
C10500D - PANO
SiX 650HD-E - PANO C10500D
XID-C15DP C10500D
- Ceph
- Ceph - Ceph XID-C24DS(Scan)
XID-C24DS(Scan) SDX-4336CP (One shot) PaxScan 4336X(One shot, Large Size)
PaxScan 4336X(One shot, Large Size) PaxScan 2530C(One shot, Standard
PaxScan 2530C(One shot, Standard Size)
Size)
Chinrest Chinrest Chinrest

Head rest Head rest Head rest

Automatic Collimator Automatic Collimator Automatic Collimator

Exposure switch Exposure switch Exposure switch

Emergency stop switch Emergency stop switch Emergency stop switch

Console PC set Console PC set Console PC set

CT exams CT exams CT exams

Automatic
Panoramic exams Panoramic exams Panoramic exams
Collimator
Cephalometric exams Cephalometric exams Cephalometric exams

TFT LCD type(Normally black) TFT LCD type(Normally black) TFT LCD type(Normally black)
Display Type
*1280x800 pixel *1280x800 pixel *1280x800 pixel

Class I with type B applied parts Class I with type B applied parts Class I with type B applied parts
Class
according to IEC 60601-1 according to IEC 60601-1 according to IEC 60601-1

Focal size 0.5 0.5 0.5

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 510(k) Submission- RCT700

Field of
160x100mm (Max.) 90x90mm 90x90mm
View(CT)

X-ray Voltage 60~90kVp 60~90kVp 60~90kVp

X-ray Current 4~17mA 4~17mA 4~17mA

Total Filtration 2.75 ㎜ Al equivalent 2.6 ㎜ Al equivalent 2.6 ㎜ Al equivalent

CT SiX 650HD-E: 150㎛ C10900D: 200㎛ C10900D: 200㎛

C10500D: 100㎛ C10500D: 100㎛ C10500D: 100㎛

PANO SiX 650HD-E: 150㎛

Detecto
r Pixel XID-C15DP: 100㎛
size
Ceph (Scan) XID-C24DS: 100㎛ XID-C24DS: 100㎛

PaxScan 4336X: 139㎛ SDX-4336CP: 150㎛ PaxScan 4336X: 139㎛

Ceph(One shot)
PaxScan 2530C: 139㎛ PaxScan 2530C: 139㎛

CT SiX 650HD-E: 1.39 C10900D: 1.39 C10900D: 1.39

C10500D: 1.31 C10500D: 1.31 C10500D: 1.31

PANO SiX 650HD-E: 1.31

Magnifi XID-C15DP: 1.31
cation
Ceph (Scan) XID-C24DS: 1.11 XID-C24DS: 1.11

PaxScan 4336X: 1.13 SDX-4336CP: 1.13 SDX-4336CP: 1.13

Ceph(One shot)
PaxScan 2530C: 1.12

CT : below 14sec CT : 14sec CT : 14sec

Scan time
Pano : below 14sec Pano : 14sec Pano : 14sec

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 510(k) Submission- RCT700

Ceph[Scan type] : below 18sec Ceph[Scan type] : below 18sec

Ceph[One shot type]: Ceph[One shot type, α-Multi3D]: Ceph[One shot type, α-Multi3D]:
below 2sec 0.3sec~3.0sec 0.3sec~3.0sec
Format compatible DICOM 3.0 Format compatible DICOM 3.0 Format compatible DICOM 3.0 Format compatible

Image Viewing Software RayScan RayScan RayScan

Image acquisition Giga-Ethernet Network Giga-Ethernet Network Giga-Ethernet Network

Total Height Max 2,296mm Max 2,296mm Max 2,296mm

1) Computed Tomography(CT) +
Panoramic(PANO)=150kg(331lb) ±
10% 1) Computed Tomography(CT) +
Panoramic(PANO)=148kg(326lb) ±
2) Computed Tomography(CT) + 10%
1) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
Panoramic(PANO)=148kg(326lb) ±
(Scan type)= 166kg (366lb) ± 10% 2) Computed Tomography(CT) +
10%
Panoramic(PANO) + Ceph
Weight 3) Computed Tomography(CT) + (Scan type)=164kg (362lb) ± 10%
2) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
Panoramic(PANO) + Ceph
(One shot type, installed in Standard 3) Computed Tomography(CT) +
(One shot type)=165kg(364lb) ± 10%
size)= 166kg (366lb) ± 10% Panoramic(PANO) + Ceph
rlwhs
(One shot type)=165kg(364lb) ± 10%
4) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Large size)
166kg (366lb) ± 10%
Type of
Wall or floor mount Wall or floor mount Wall or floor mount
installation
Patient position Standing / Wheelchair Standing / Wheelchair Standing / Wheelchair

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 510(k) Submission- RCT700

IEC 60601-1
IEC 60601-1-1
IEC 60601-1 IEC 60601-1
IEC 60601-1-3
IEC 60601-1-3 IEC 60601-1-3
Applicable IEC 60601-2-7
IEC 60601-2-28 IEC 60601-2-28
Standards IEC 60601-2-28
IEC 60601-2-63 IEC 60601-2-63
IEC 60601-2-32
IEC 60601-1-2 IEC 60601-1-2
IEC 60601-2-44
IEC 60601-1-2

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 510(k) Submission- RCT700

Safety and Effectiveness Information

Electrical, mechanical and environmental safety testing according to standard of

IEC 60601-1: 2005 + CORR.1(2006) + CORR.2(2007), IEC 60601-1-3: 2008(Second Edition), IEC
60601-2-28: 2010(Second Edition) and IEC 60601-2-63: 2012(first Edition) were performed.
EMC testing was conducted in accordance with the standard IEC 60601-1-2: 2007(Edition 3.0).

The software of RCT700 has been validated according to FDA “Guidance for the Content d Premarket
Submissions for Software Contained in Medical Devices” and applicable requirements contained in
the guidance document.

Bench testing was conducted according to FDA Guidance “Format for Traditional and Abbreviated
510(k)s, section 18, Performance Testing – Bench”
Bench testing is used to assess whether or not the parameter measured required for describing
functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the
designated tolerance.
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4
and IEC 61223-3-5.

All test results were satisfactory.

Non-clinical considerations were conducted in accordance with FDA Guidance "Guidance for the
submissions of 510(k)'s for Solid State X-ray Imaging Devices".
All test results were satisfactory.

Both of the predicate device and proposed devices were test and measured by IEC 62220-1.
RCT700 system’s new sensor and compared with the predicate device with regard to Modulation
Transfer Function (MTF) and Device Quantum Efficiency (DQE) and Noise to power spectrums (NPS).

Based on Non-Clinical Test results of the new detector SiX-650HD-E of the subject device, the
measured pixel sizes of the new sensor (SiX-650HD-E) are similar to that of the predicate device
(C10900D). Therefore, compared to the predicate device, the test patterns of the new sensor images
show the test subjects without aliasing phenomenon throughout the same spatial frequency as the
predicate device. Moreover, the new SiX-650HD-E sensor has performed similarly or better than the
predicate device in terms of the overall NPS performance, give the NPS variation in low frequency
(~0.6 lp/mm). The new sensor also exhibits consistently better performances in terms of MTF.
For the new detector XID-C15DP of RCT700, the Non-Clinical test results demonstrated the similar
characteristics in terms of MTF, NPS, and DQE performance compared to C10500D detector of the
subject and predicate device. All performance parameter for both detectors have shown similar results.

In conclusion, the diagnostic image quality of the new sensor is equal or better than those of the
predicate device and there is no significant in efficiency and safety.

RCT710 complies with FDA standards such as 21 CFR 1202.30 and 21 CFR 1020.31 and CFR
1020.33.

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 510(k) Submission- RCT700

Clinical considerations were conducted according to FDA Guidance “Format for Traditional and
Abbreviated 510(k)s, section 20”.

Clinical images were provided these images were not necessary to establish substantial
equivalence based on the modifications to the device but they provide further evidence in addition to
the laboratory performance data to show that the complete system works as intended.
For clinical testing, two licensed practitioners/clinicians observed and verified that dental X ray system
from RCT700.
The clinical imaging samples are collected from the new detector on propose device at the 2 offices
where the predicate device is installed on clinical consideration report for the clinical test images.
These images were gathered from the new detector installed with RCT700 on any protocols with
random patient age, gender, and size. As licensed practitioners or clinician diagnoses of the images, it
might be proved that the clinical diagnosis and structures are acceptable in the region of interests.

Conclusions
The proposed device and the predicate device have the same indications for use and demonstrate
the similar technical characteristics. As demonstrated in the non-clinical considerations and bench test,
the RCT700 performed similar the predicate device in various performance parameters such as DQE,
MTF and NPS. The electrical requirement of the new device is evaluated and mitigated in electrical
safety test, EMC test. Quality assurance procedures are adhered to, and meeting the specifications
and functional requirements is demonstrated via testing.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the
information provided in this premarket notification. Ray Co., Ltd. concludes that RCT700 is safe and
effective and substantially equivalent to the predicate device as described herein.

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