Rayence Co., Ltd.

July 23, 2020

℅ Mr. Dave Kim
President
Mtech Group
7707 Fannin St., Ste 200, V111
HOUSTON TX 77054

Re: K201796
Trade/Device Name: 1717SCV, 1717SGV
Regulation Number: 21 CFR 892.1680
Regulation Name: Stationary x-ray system
Regulatory Class: Class II
Product Code: MQB
Dated: June 19, 2020
Received: June 30, 2020

Dear Mr. Kim:

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. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. 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) for

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.16
Silver Spring, MD 20993
www.fda.gov
K201796 - Mr. Dave Kim Page 2

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For
Thalia T. Mills, Ph.D.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics
and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
510(k) Submission – 1717SCV / 1717SGV K201796

1. 510(k) Summary (K201796)

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

Date 510k summary prepared: June 24, 2020

Submitter’s Name, address, telephone number, a contact person:

Submitter’s Name : Rayence Co., Ltd.

Submitter’s Address: 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea
Submitter’s Telephone: +82-31-8015-6459
Contact person: Mr. Kee Dock Kim / RA Team Manager / +82-31-8015-6459
Official Correspondent: Dave Kim (davekim@mtech-inc.net)
Address: 7707 Fannin St. Ste 200-V111, Houston, TX 77054
Telephone: +713-467-2607

Name of the device, including the trade or proprietary name if applicable, the common or usual name
and the classification name, if known:

Trade/proprietary name: 1717SCV / 1717SGV

Model Name : 1717SCV_127µm, 1717SCV_140µm
1717SGV_127µm, 1717SGV_140µm
Common Name : Digital Flat Panel X-ray Detector
510(k) Number
Regulation Number : 21 CFR 892.1680
Regulation Name : Stationary X-ray System
Product Code : MQB
Product Class : Class 2

Predicate Device #1:

Trade/Device Name : 1717scc_127um And 1717scc_140um
Common Name : Digital Flat Panel X-ray Detector
510(k) Number : K171420
Regulation Number : 21 CFR 892.1680
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510(k) Submission – 1717SCV / 1717SGV K201796

Regulation Name : Stationary X-ray System

Product Code : MQB
Product Class : Class 2

Predicate Device #2:

Trade/Device Name : 1717sgc_127um And 1717sgc_140um
Common Name : Digital Flat Panel X-ray Detector
510(k) Number : K171419
Regulation Number : 21 CFR 892.1680
Regulation Name : Stationary X-ray System
Product Code : MQB
Product Class : Class 2

2. Device Description
1717SCV / 1717SGV is a digital solid state X-ray detector that is based on flat-panel technology. This
radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor.
This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and
digitalize X-ray images for radiographic diagnosis.
1717SCV and 1717SGV have the same Hardware, Software and components.
The type of scintillator layer are different: Cesium Iodide for 1717SCV and Gadolinium Oxsulfide for
1717SGV. Scintillator is a phosphor that produces scintillations.
The subject detectors are not wireless, but they are connected to a viewing station by ethernet
connection. Also, the subject detectors have an Automatic Exposure Control (AEC) feature.

The RAW files can be further processed as DICOM compatible image files by separate console SW
(K190866 / Xmaruview V1 (Xmaru Chiroview, Xmaru Podview)/ Rayence Co.,Ltd.) for a radiographic
diagnosis and analysis.
The software used with the subject detectors is the same as the software XmaruView V1 used with the
predicate K190866.

3. Indication for use

1717SCV and 1717SGV X-ray detectors, 127um and 140um, are indicated for digital imaging solution
designed for general radiographic system for human anatomy. It is intended to replace film or screen based
radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

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510(k) Submission – 1717SCV / 1717SGV K201796

4. Summary of Design Control Risk management

1717SCV / 1717SGV digital X-ray detector is a modification of 1717SCC (K171420) and 1717SGC
(K171419). 1717SCV / 1717SGV was developed for the purpose of retrofitting the stationary X-ray
system with a film detector.
The risks and the hazardous impact of the device modification were analyzed with FMEA method. The
specific risk control and protective measures to mitigate the risks from the modification were reviewed
and implemented in the new product design phase. The overall assessment concluded that all risks and
hazardous conditions identified arising from the design change were successfully mitigated and accepted.

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510(k) Submission – 1717SCV / 1717SGV K201796

5. Summary of the technological characteristics of the device compared to the

predicate device:
1717SCV / 1717SGV detector described in this 510(k) has the same indications for use and similar technical
characteristics as its predicate device, 1717SCC (K171420) and 1717SGC (K171419).

5.1 Comparison table

Proposed Predicate
Characteristic Rayence Co.,Ltd. Rayence Co.,Ltd.
1717SCV / 1717SGV 1717SCC and 1717SGC

Feature

510(k) number - K171420 K171419

1717SCC and 1717SGC X-ray 1717SCC and 1717SGC X-ray detectors, Same
detectors, 127um and 140um, are 127um and 140um, are indicated for
indicated for digital imaging solution digital imaging solution designed for
designed for general radiographic general radiographic system for human
Intended Use system for human anatomy. It is anatomy. It is intended to replace film or
intended to replace film or screen screen based radiographic systems in all
based radiographic systems in all general purpose diagnostic procedures.
general purpose diagnostic procedures. Not to be used for mammography.
Not to be used for mammography.
Detector Type Amorphous Silicon, TFT Amorphous Silicon, TFT Same
1717SCV CsI:Tl 1717SCC CsI:Tl Same
Scintillator
1717SGV Gd2O2S:Tb 1717SGC Gd2O2S:Tb
Imaging Area 17 x 17 inches 17 x 17 inches Same
127 : 3328 X 3328 127 : 3328 X 3328 Same
Pixel matrix 140 : 3072 X 3072 140 : 3072 X 3072
Pixel pitch 127 µm, 140 µm 127 µm, 140 µm Same
127 type: 3.93 lp/mm 127 type: 3.93 lp/mm Same
Resolution 140 type: 3.57 lp/mm 140 type: 3.57 lp/mm
A/D conversion 14 / 16 bit 14 bit for 127 μm / 16 bit for 140 μm Same
127 type: 0.200 127 type: 0.176 Similar
1717SCV 1717SCC
140 type: 0.111 140 type: 0.106
MTF (3 lp/mm)
127 type: 0.120 127 type: 0.119
1717SGV 1717SGC
140 type: 0.103 140 type: 0.100
127 type: 0.675 127 type: 0.644 Similar
1717SCV 1717SCC
140 type: 0.682 140 type: 0.685
DQE (0.1 lp/mm)
127 type: 0.405 127 type: 0.401
1717SGV 1717SGC
140 type: 0.414 140 type: 0.383
Preview time ≤2 ≤2 Same
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510(k) Submission – 1717SCV / 1717SGV K201796

RAW RAW Same

Data output *The RAW files are convertible into *The RAW files are convertible into
DICOM 3.0 by console S/W DICOM 3.0 by console S/W
Dimensions 460 x 460 x 15.6 mm 460 x 460 x 15.5 mm Similar
Weight 4.0 kg 4.0 kg Same
General Radiology system or Portable General Radiology system or Portable Same
system system
Application Available with upright stand, table, Available with upright stand, table,
universal stand. universal stand.
Power
Name RP005A RS1717 Diffe-
rent

Feature

Type POE Power supply

Input ; 100-240 V a.c., 50/60 Hz, 1.2 A Input: AC 100-240V, 50/60Hz 1.0 - 0.5A
Rating
Output ; 54 V d.c., 0.75 A Output : 24V, 1.60A
Connection with
With LAN cable With Link cable
detector

5.2 Scintillator layer

1717SCV and 1717SGV have the same Hardware, Software and components.
But *scintillator layer are different. ( * scintillator : a phosphor that produces scintillations)
Proposed Predicate
CsI
1717SCV 1717SCC
(Cesium Iodide)
Gd2O2S:Tb
1717SGV 1717SGC
(Gadolinium Oxysulfide)

5.3 Recommended Generator Specifications

Model Manufacture Specification

32kW 40kW 50kW

Communications & Power
CMP 200 kVp 40-125 40-150
Industries
mA 10-400 10-500 10-630
kVp 40-150
EDITOR HFe 501 Rontgenwerk Bochum
mA 10-630
UD150L-40E/40F Shimadzu kVp 40-150
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510(k) Submission – 1717SCV / 1717SGV K201796

@100 kVp- 500

mA
@80 kVp- 630
kVp 125/150
PXR-321B Poskom Co.,Ltd.
mA 500
6. Summary of Performance Testing

1717SCV and 1717SGV digital flat panel X-ray detectors in comparison with 1717SCC and 1717SGC have
the same indications for use, the same imaging area (17 x 17), based on the same scintillator material (CsI:Tl
for SCV and SCC, Gd2O2S:Tb for SGV and SGC ), same resolution performance. The pixel matrix for
each pixel pitch size (127 um and 140 um) for both the subject devices and the predicate devices are
identical. The recommended generator specifications for both the subject device and the predicate device
remains the same.
The non-clinical test report for each subject device was prepared and submitted to FDA separately to
demonstrate the substantial equivalency of the subject devices compared to each respective predicate device.
The non-clinical test report contains the MTF, DQE and NPS test results of 1717SCV and 1717SGV by
using the identical test equipment and same analysis method described by IEC 62220-1.

The MTF and DQE represent the ability to visualize object details of a certain size and contrast. 1717SCV
and 1717SGV have similar MTF and DQE performance in comparison with 1717 SCC and 1717SGC,
respectively, at all spatial frequencies.

The power adapter for 1717SCV and 1717SGV has been updated to RP005A from RS1717.
The electrical safety test data demonstrates that the new power adapter is safe and effective.

7. Summary for any testing in the submission:

➢ Electrical, mechanical, environmental safety and performance testing according to standard IEC
60601-1: 2005, COR1:2006, COR2:2007, AMD1:2012 (Medical electrical equipment Part
1:General requirements for basic safety and essential performance)
➢ EMC testing were conducted in accordance with standard IEC 60601-1-2: 2014.
➢ IEC 62220-1 Ed 1.0 Medical electrical equipment-Characteristics of digital X-ray imaging devices
Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
➢ Non-clinical consideration according to FDA Guidance “Guidance for the Submissions of 510(k)’s
for Solid State X-ray Imaging Devices”
➢ “Guidance for the Contents of Premarket Submission for Software Contained in Medical Device”

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510(k) Submission – 1717SCV / 1717SGV K201796

8. Conclusions:
Based on the non-clinical consideration for both devices, Rayence, the sponsor, claims the substantial
equivalency between the subject devices and their predicate devices in terms of diagnostic image quality
without new concern for safety and effectiveness.