October 20, 2022

iRay Technology Taicang Ltd.

℅ Junjie Qian
Registration & Regulation Affairs Engineer
No. 33 Xinggang Rd., Taicang Port Economic Technological
Development Zone
Taicang, Jiangsu 215434
CHINA

Re: K222886
Trade/Device Name: Mercu1717V
Regulation Number: 21 CFR 892.1680
Regulation Name: Stationary x-ray system
Regulatory Class: Class II
Product Code: MQB
Dated: September 13, 2022
Received: September 23, 2022

Dear Junjie Qian:

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

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.30
Silver Spring, MD 20993
www.fda.gov
K222886 - Junjie Qian Page 2

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
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 ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurel M.
Burk -S
Laurel Burk, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging Devices
and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
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: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K222886

Device Name
Mercu1717V

Indications for Use (Describe)

Mercu1717V Digital Flat Panel Detector is indicated for digital imaging solutions designed to provide general
radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen
systems in all general–purpose diagnostic procedures. The device is not intended for mammography or dental
applications.

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
[email protected]
“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 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 iRay Technology Taicang Ltd. [510(k)] Application

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)
K222886

1. Date Prepared [21 CFR 807.92(a)(1)]

July 13, 2022

2. Submitter’s Information [21 CFR 807.92(a)(1)]

Company Name: iRay Technology Taicang Ltd.

Company Address: No.33 Xinggang Road, Taicang Port Economic and
Technological Development Zone, Jiangsu, China 215434
Contact Person: Junjie. Qian
Phone: 0512-53690872
Fax: 0512-53690872
Email: [email protected]

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name: Digital Flat Panel Detector

Common Name: Solid State X-Ray Imager
Model Name: Mercu1717V
Classification Name: Stationary X-Ray System
Product Code: MQB
Regulation Number: 21 CFR 892.1680
Device Class: Class II

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 iRay Technology Taicang Ltd. [510(k)] Application

4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)]

The identification predicates within this submission are as follows:

Manufacturer: iRay Technology Co., Ltd.
Trade Name: Flat Panel Detectors
Model Name: Venu1717X
Product Code: MQB
Classification Name: Stationary X-Ray System
Regulation Number: 21 CFR 892.1680
Device Class: Class II
FDA 510 (k) #: K221714
5. Identification of Reference Devices(s) [21 CFR 807.92(a)(3)]
Manufacturer: CareRay Digital Medical Technology Co., Ltd.
Trade Name: X-ray Flat Panel Detectors
Model Name: CareView 3600RF
Product Code: MQB
Classification Name: Stationary X-Ray System
Regulation Number: 21 CFR 892.1680
Device Class: Class II
FDA 510 (k) #: K202995

6. Description of the Device [21 CFR 807.92(a)(4)]

Mercu1717V Digital Flat Panel Detectors (Hereinafter referred to as Mercu1717V)
supports dynamic imaging and static imaging.
The sensor plate of Mercu1717V is direct-deposited with CsI scintillator to achieve the
conversion from X-ray to visible photon. The visible photons are transformed to
electron signals by diode capacitor array within TFT panel, which are composed and
processed by connecting to scanning and readout electronics, consequently to form a
panel image by transmitting to PC through the cable.

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iRay Technology Taicang Ltd. [510(k)] Application

The major function of the Mercu1717V is to convert the X-ray to digital image, with
the application of high-resolution X-ray imaging. Mercu1717V can get single image
and it also can get dynamic image. Both kinds of detectors are the key component of
DR system, enable to complete the digitalization of the medical X-ray imaging with
the DR system software.
The iRay DR used for digital X-ray radiography image from the digital flat panel
detectors. iRay DR is used to handle the DICOM protocol (DICOM 3.0). iRay DR has
many functions such as image acquisition, image enhancement processing and editing
image or information.

7. Intended Use [21 CFR 807.92(a)(5)]

7.1. Indications for use

Mercu1717V digital flat panel detector is indicated for digital imaging solutions
designed to provide general radiographic diagnosis for human anatomy including
both adult and pediatric patients. It is intended to replace film/screen systems in
all general–purpose diagnostic procedures. The device is not intended for
mammography or dental applications.
6.2. Suitable patient
It is suitable for providing digital X-ray imaging for DR system to provide general
radiographic diagnosis for human anatomy including both adult and pediatric
patients, but not intended for mammography or dental applications. The
remaining notes depend on the DR system.
6.3. Processing of input and output
Mercu1717V Digital flat panel detector get signal from high-voltage generator,
and then it gets ready to output radiographic imaging for diagnosis of disease,
injury, or of any applicable health problem to iRayDR installed in PC.
iRayDR get raw image and output clinical image after enhancement processing
for raw image is finished.

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 iRay Technology Taicang Ltd. [510(k)] Application

8. Technological Characteristic [21 CFR 807.92(a)(6)]

Predicate Device: Reference Device: Proposed Device:
Item Venu1717X Digital CareView 3600RF X-ray Mercu1717V Digital Flat Panel
Flat Panel Detector Flat Panel Detector Detector
510(K) Number K221714 K202995 K222886
This equipment The CareView 3600RF
provides digital X-ray detector is indicated for
imaging for diagnosis digital imaging solution
of disease, injury, or designed for providing
any applicable health general radiographic
Mercu1717V Digital Flat Panel
problem. The image is diagnosis of human
Detector is indicated for digital
obtained as the result of anatomy. It is intended to
imaging solution designed for
Intended Use X-ray passing through replace radiographic
providing general radiographic
the human body and film/screen systems in all
system in all general-purpose
detected by the general-purpose
diagnostic procedures.
equipment. diagnostic procedures.
iRay will provide This product is not
equipment and software intended for
support for integration mammography
of system. applications.
Venu1717X is Mercu1717V is indicated for
indicated for digital digital imaging solutions
imaging solutions designed to provide general
designed to provide radiographic diagnosis for
Indications for general radiographic human anatomy including both
/
Use diagnosis for human adult and pediatric patients. It is
anatomy including intended to replace film/screen
adults only. It is systems in all general–purpose
intended to replace diagnostic procedures. The
film/screen systems in device is not intended for

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 iRay Technology Taicang Ltd. [510(k)] Application

Predicate Device: Reference Device: Proposed Device:

Item Venu1717X Digital CareView 3600RF X-ray Mercu1717V Digital Flat Panel
Flat Panel Detector Flat Panel Detector Detector
all general–purpose mammography or dental
diagnostic procedures. applications.
Classification Stationary X-ray
Stationary X-ray system Same
Name system
Product Code MQB MQB Same
Regulation
21 CFR 892.1680 21 CFR 892.1680 Same
Number
Panel: Radiology Radiology Same
Classification: II II Same
X-Ray Absorber
CSI GOS CSI
(Scintillator):
Installation Type: Wired Same Same
Readout
Thin Film Transistor Same Same
Mechanism:
Min. 1024 × 1024 pixels
Image Matrix (@binning 3×3)
3072 × 3072 pixels 5632 × 2816 pixels
Size: Max.3072 ×3072 pixels
(@binning 1×1)
Pixel Size: 139μm 154 μm 139μm
ADC Digitization 16 bit Same Same
Min.285mm×285mm
Effective Imaging (@zoom on)
427mm×427mm 867.5mm × 433.1 mm
Area: Max.427mm × 427mm
(@zoom off)
Spatial
Min. 3.4 lp/mm Same Same
Resolution:

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 iRay Technology Taicang Ltd. [510(k)] Application

Predicate Device: Reference Device: Proposed Device:

Item Venu1717X Digital CareView 3600RF X-ray Mercu1717V Digital Flat Panel
Flat Panel Detector Flat Panel Detector Detector
0.75 at 0.5lp/mm 0.78 at 0.5lp/mm
MTF 0.66 at 1 lp/mm
0.5 at 1lp/mm 0.55 at 1lp/mm
Detective
0.28 at 0.5 lp/mm 0.4 at 0.5 lp/mm
Quantum 0.28 at 1 lp/mm
0.20 at 1 lp/mm 0.35 at 1 lp/mm
Efficiency (RQA5, 2.5μGy)
(RQA5, 3.2μGy) (RQA5, 2.5μGy)
(DQE)
Power
Max. 20W ~50W 18 W
Consumption:
Gigabit
Communications: Same Same
Ethernet
Imaging protect
Carbon Fiber Plate Same Same
Plate:
Cooling: Air cooling Same Same
Protection against
IPX1 / IPX1
matter/water
460 mm× 460 mm × 916.9 mm × 486.4 mm ×
Dimensions: 460 mm × 460 mm × 15mm
15 mm 42.8 mm
3.5fps@1×1 5fps@1×1
Frame rate / 15fps@2×2 20fps@2×2
25fps@4×4 30fps@3×3
Temperature: +5 ~ Temperature: +10 ~ Temperature: +10 ~ +35℃
+35℃ +40℃ Humidity: 20 ~ 90%
Humidity: 30 ~ 80% Humidity: 30 ~ 75% (Non-Condensing)
Operation:
(Non-Condensing) (Non-Condensing) Atmospheric pressure: 700 ~
Atmospheric pressure: Atmospheric pressure: 700 1060 mbar
70 ~ 106 ~ 1060 hPa Altitude: Max. 3000 meters

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 iRay Technology Taicang Ltd. [510(k)] Application

Predicate Device: Reference Device: Proposed Device:

Item Venu1717X Digital CareView 3600RF X-ray Mercu1717V Digital Flat Panel
Flat Panel Detector Flat Panel Detector Detector
kPa Altitude: Max. 3000
Altitude: Max. 3000 meters
meters
Temperature: 10 ~
Temperature: -20 ~ +55℃
55℃ Temperature: -10 ~ +55℃
Humidity: 10 ~ 90%
Humidity: 10 ~ 90% Humidity: 10 ~ 95%
Storage and (Non-Condensing)
(Non-Condensing) (Non-Condensing)
Transportation: Atmospheric pressure: 700
Atmospheric pressure: Atmospheric pressure: 700 ~
（detector） ~ 1060 hPa
70 ~ 106 kPa 1060 mbar
Altitude: Max. 3000
Altitude: Max. 3000 Altitude: Max. 3000 meters
meters
meters
CareRay software The Mercu1717V Digital Flat
provides a set of Panel Detector is supported by
predefined APIs software, named iRayDR.
（Application
Programming The iRayDR used for getting
Interfaces ）, an adapter digital X-ray radiography
layer between a CareView images from the digital flat
Software iDetector 3600RF detector and an panel detectors. iRay DR is
upstream program on the used to handle the DICOM
client side, commonly protocol (DICOM 3.0). iRay
known as DROC（Digital DR has many functions such as
Radiography Operator patient registration, image

Console） . acquisition, image display,

DROC communicates image processing and image

with the CareRay archiving.

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 iRay Technology Taicang Ltd. [510(k)] Application

Predicate Device: Reference Device: Proposed Device:

Item Venu1717X Digital CareView 3600RF X-ray Mercu1717V Digital Flat Panel
Flat Panel Detector Flat Panel Detector Detector
detectors via APIs. In Image processing refers to some
general, APIs are provided post-processing tools for the
in the form of DLL acquired image, including three
（Dynamic-Link parts of the common tools, the

Libraries） files. The image post-processing tools and

upstream program imports the measurement tools.

these DLL files and calls Common tools: zoom, rotate,

relevant API commands to etc.

manipulate a CareView Post-processing tools: adjust

3600RF detector-query image contrast, brightness, etc.

status, select application Measurement tools: line

mode, calibrate detector, measurement, angle

acquire images, and measurement.

preprocess images-without
caring about the iRayDR software is of

implementation details of Moderate level of concern.

the algorithm or workflow

under the hood.

9. System requirements to operate with other radiographic system components

1) Recommended Generator Specification:

Energy range: 40~150kVp
mA range: 10~1000mA (depending on the generator power)
ms range: 10~6300ms to produce 0.1~1000mAs (depending on the generator power)

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 iRay Technology Taicang Ltd. [510(k)] Application

Note: To our best knowledge, the detector is compatible with the X-ray generators
with the specifications described above. If you have any questions regarding the
compatibility issue for other generators, please contact the distributor or iRay’s
service office.
2) Peripheral hardware: Mercu1717V connected via wired communication.
Operating System: Windows 10, 64bit
CPU: Intel Core i5 8400 2.8G
Memory: 16G DDR4
Hard Disk: 1T SSD
LAN Card: Intel Pro EXP9301CT PRO
Gigabit Network Adapter with PCIe interface

3) X-ray exposure mode

The digital flat panel detector gets ready to output image after it receive signal form
high-voltage generator. The digital flat panel detector stops outputting image when
there is no signal from high-voltage generator

10. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

1) Electrical Safety and EMC testing:

Electrical, mechanical, environmental safety according to IEC/ES 60601-1 was
performed, and EMC testing was also conducted in accordance with IEC 60601-1-2.
All test results are meet the standard requirements.

2) Biological Evaluation:
The digital flat panel detector is not intended to be touched by patient, so evaluation
of bio-compatibility is not necessary.
3) Non-clinical Considerations:

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 iRay Technology Taicang Ltd. [510(k)] Application

The non-clinical studies have been performed and the results have shown that the
Mercu1717V digital flat panel detector is substantially equivalent to the predicate
devices on the Market (K221714)
Parameter about image quality is equal to or better than predicate device parameter
According to the Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices, the software iRayDR classifies the hazards, defines
requirements specification and design specification, all the specification pass all the
test cases and complies the intended design specification
4) Clinical Consideration:
Intended use, fundamental scientific technology, regulatory requirement, non-clinical
performance, labeling, quality-assurance program keep the same with those of
predicate device. Additionally, as mentioned in clinical considerations in ‘Guidance
for the Submission of 510(k)s for Solid State X-ray Imaging Devices’,

11. Conclusion [21 CFR 807.92(b)(3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and
based on the information provided in this premarket notification, iRay Technology
Taicang Ltd. concludes that Mercu1717V is substantially equivalent to predicate
device with regards to safety and effectiveness.

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