Wireless Digital Flat Panel Detector

K161730 · Iray Technology (Shanghai) , Ltd. · MQB · Dec 8, 2016 · Radiology

Device Facts

• Record ID: K161730
• Device Name: Wireless Digital Flat Panel Detector
• Applicant: Iray Technology (Shanghai) , Ltd.
• Product Code: MQB · Radiology
• Decision Date: Dec 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Indications for Use

Mars1417V-PSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications.

Device Story

The Mars1417V-PSI is a wireless digital flat panel detector (FPD) used in general radiographic imaging. It utilizes a Gd2O2S scintillator to convert X-rays into visible light, which is then transformed into electronic signals by a diode capacitor array within a TFT panel. The device operates in single-frame mode and features an inner trigger module that automatically detects X-ray exposure to initiate image acquisition. The resulting digital images are transmitted via wired (Gigabit Ethernet) or wireless (IEEE 802.11a/b/g/n) connection to a PC running iRay DR software. The system is operated by healthcare professionals in clinical settings to manage patient registration, image acquisition, processing, and forwarding. By replacing traditional film/screen systems, the device enables digital X-ray radiography, facilitating faster image availability and diagnostic review for clinicians, which supports timely clinical decision-making and patient care.

Clinical Evidence

Bench testing included DQE, MTF, sensitivity linearity, and spatial resolution, confirming performance equivalent to the predicate. Clinical evidence consisted of a concurrence study of 30 clinical images comparing the subject device to the predicate, demonstrating no significant difference in image quality.

Technological Characteristics

Wireless/portable FPD; 36cm x 43cm active area; Gd2O2S scintillator; TFT readout; 14-bit ADC; 2304 x 2800 pixel matrix; 150μm pixel pitch; carbon fiber plate; air cooling. Connectivity: Gigabit Ethernet, IEEE 802.11a/b/g/n. Complies with IEC/ES 60601-1 and IEC/EN 60601-1-2. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for digital radiographic diagnosis of human anatomy in general-purpose diagnostic procedures. Suitable for patients requiring digital X-ray imaging. Not intended for mammography or dental applications.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• ViZion DR + Wireless (K152279)

Reference Devices

• Opal-RAD (K063337)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads facing right, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

December 8, 2016

iRay Technology (Shanghai) Ltd. % Mr. Wei Pan Registration & Regulatory Affairs Manager Room 202, Building 7, No. 590, Ruiqing Road Shanghai, 201201 CHINA

Re: K161730

Trade/Device Name: Wireless Digital Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: November 11, 2016 Received: November 18, 2016

Dear Mr. Pan:

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K161730

Device Name Wireless Digital Flat Panel Detector

### Indications for Use (Describe)

Mars1417V-PSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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

[e-mail]

"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 Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

{3}------------------------------------------------

# SECTION 7

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

SECTION 7 - 1 of 8

{4}------------------------------------------------

### 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

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

October 19, 2015

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

| Company Name: | iRay Technology (Shanghai) Ltd. |
|------------------|------------------------------------------------------------|
| Company Address: | RM 202, Building 7, No. 590, Ruiqing RD., Zhangjiang East, |
| | Pudong, Shanghai, China 201201 |
| Contact Person: | Mr. Wei Pan |
| Phone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

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

| Trade Name: | Wireless Digital Flat Panel Detector |
|----------------------|--------------------------------------|
| Common Name: | Flat Panel Detector |
| Model Name: | Mars1417V-PSI |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |

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

The identification predicates within this submission are as follows:

| Manufacturer: | Viztek LLC |
|---------------|----------------------|
| Trade Name: | ViZion DR + Wireless |
| Model Name: | ViZion DR + Wireless |
| Product Code: | MQB |

# SECTION 7 - 2 of 8

{5}------------------------------------------------

Classification Name: Stationary X-Ray System K152279 FDA 510 (k) #:

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

Mars1417V-PS1 Wireless Digital Flat Panel Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 36cm×43cm.

The sensor plate of Mars1417V-PSI Wireless Digital Flat Panel Detector is direct-deposited with Gd2O2S 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 user interface.

The major function of the Mars1417V-PSI Wireless Digital Flat Panel Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical Xray imaging with the DR system software.

The iRay DR used for getting Digital X -ray radiography images from the flat panel detectors. iRay DR is used to handle the DICOM protocol (DICOM 3.0), iRay DR is responsible for the DR equipment management, acquisition and processing functions, to provide patient registration, scanning, image processing and forwarding, and other functions ..

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

#### 6.1. Intended Use

Mars1417V-PSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This 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 conventional photography but not intended for mammography or dental applications. The remaining notes depend on the DR system.

### 6.3. Processing of input and output

# SECTION 7 - 3 of 8

{6}------------------------------------------------

When FPD works continuously, it can automatically distinguish X-ray and output an imaging for diagnosis of disease, injury, or of any applicable health problem

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

| Item | Proposed Device:<br>Wireless Digital Flat Panel<br>Detector | Predicate Device:<br>ViZion DR + Wireless |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)<br>Number | To be assigned | K152279 |
| Intended Use | The Mars1417V-PSI Wireless<br>Digital Flat Panel Detector is<br>indicated for digital imaging<br>solution designed for providing<br>general radiographic system in all<br>general purpose diagnostic<br>procedures. | ViZion DR + Wireless is intended<br>for digital image capture use in<br>general radiographic<br>examinations, wherever<br>conventional screen-film systems<br>may be used, excluding<br>fluoroscopy, angiography and<br>mammography. |
| Classification<br>Name | Stationary X-ray system | Stationary X-ray system |
| Product Code | MQB | MQB |
| Regulation<br>Number | 21 CFR 892.1680 | 21 CFR 892.1680 |
| Panel: | Radiology | Radiology |
| Classification: | II | II |
| X-Ray Absorber<br>(Scintillator): | Gd2O2S | Gd2O2S |
| Installation Type: | Wireless, Portable | Wireless, Portable |
| Readout<br>Mechanism: | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size: | 2304 × 2800 pixels | 2304 × 2800 pixels |
| Pixel Pitch: | 150μm | 150μm |
| ADC Digitization | 14 bit | 14 bit |
| Item | Proposed Device:<br>Wireless Digital Flat Panel<br>Detector | Predicate Device:<br>ViZion DR + Wireless |
| Effective Imaging<br>Area: | 355 mm × 434 mm | 355 mm × 434 mm |
| Spatial Resolution: | Min. 3.4lp/mm | Min. 3.4lp/mm |
| Modulation<br>Transfer<br>Function<br>(MTF) | 0.75 at 0.5lp/mm | 0.75 at 0.5 lp/mm |
| Detective<br>Quantum<br>Efficiency<br>(DQE) | 0.27 at 0.5 lp/mm (RQA5,<br>3.2µGy) | 0.27 at 0.5 lp/mm (RQA5,<br>3.2µGy) |
| Power<br>Consumption: | Max. 13W | Max. 13W |
| Software | Outputs a DICOM image. | Outputs a DICOM image. |
| DICOM 3 | Yes | Yes |
| Communications: | Wired: Gigabit Ethernet<br>(1000BASE-T)<br>Wireless: IEEE 802.11a/b/g/n<br>(2.4 GHz / 5 GHz) | Wired: Gigabit Ethernet<br>(1000BASE-T)<br>Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz) |
| Imaging protect<br>Plate: | Carbon Fiber Plate | Carbon Fiber Plate |
| Cooling: | Air cooling | Air cooling |
| Dimensions: | 384 mm × 460 mm × 15 mm | 384 mm × 460 mm × 15 mm |
| Operation: | Temperature: +5 ~ +35°C<br>Humidity: 30 ~ 75%<br>(Non-Condensing)<br>Atmospheric pressure: 70 ~ 106 kPa<br>Altitude: Max. 3000 meters | Temperature: +5 ~ +35°C<br>Humidity: 30 ~ 75%<br>(Non-Condensing)<br>Atmospheric pressure: 70 ~ 106 kPa<br>Altitude: Max. 3000 meters |
| Item | Proposed Device:<br>Wireless Digital Flat Panel<br>Detector | Predicate Device:<br>ViZion DR + Wireless |
| Storage and<br>Transportation: | Temperature: -20 ~ +55 °C | Temperature: -20 ~ +55 °C |
| | Humidity: 10 ~ 90%<br>(Non-Condensing) | Humidity: 10 ~ 90%<br>(Non-Condensing) |
| | Atmospheric pressure: 70 ~ 106 kPa | Atmospheric pressure: 70 ~ 106 kPa |
| | Altitude: Max. 3000 meters | Altitude: Max. 3000 meters |
| | | |
| Software | iRay DR | Opal-RAD™ (k063337) |
| | The iRay DR used for getting | Opal - RAID is a software suite of |
| | Digital X -ray radiography | web based PACS applications that |
| | images from the flat panel | was developed specifically to |
| | detectors. iRay DR is used to | handle the DICOM protocol, for |
| | handle the DICOM protocol | both transmitting and viewing |
| | (DICOM 3.0), | DICOM images and data |
| | iRay DR is responsible for the | elements. The applications were |
| | DR equipment management, | developed so that access to the |
| | acquisition and processing | PACS can occur from any |
| | functions, to provide patient | Microsoft Windows computer |
| | registration, scanning, image | with internet capabilities, and |
| | processing, image forwarding, | offer an interface that users find to |
| | image printing and other | be quite intuitive after some initial |
| | functions. | learning. The Opal-RAID |
| | | applications deal with all manner |
| | | of DICOM images These images |
| | | can be viewed, manipulated, annotated, transmitted to other facilities, printed, animated and stored using the Opal-RAID suite. The system does not produce any original medical images. |

# SECTION 7 - 4 of 8

{7}------------------------------------------------

## iRay Technology (Shanghai) Ltd

## [510(k)] Application

# SECTION 7 - 5 of 8

{8}------------------------------------------------

### iRay Technology (Shanghai) Ltd

## [510(k)] Application

# SECTION 7 - 6 of 8

{9}------------------------------------------------

### 8. 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) 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 your distributor or iRay's service office.

- 2) Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1417V-PSI detector connected via wireless or wired communication.
Operating System: Windows XP/7 32/64bit CPU: Intel Core i73.6G Memory: 4G DDR3 Hard Disk: 640 G LAN Card: Intel Pro EXP9301CT PRO Gigabit Network Adapter with PCIe interface

- 3) X-ray exposure mode
The inner trigger module is a unit can connect X-ray signal in the Mars1417V-PSI. Once there is X-ray generator exposure exist, the inner trigger module will detect the X-ray radiation and output signal to the detector. Until the exposure finished, the detector will receive a signal which represent the end of exposure from the inner trigger module and begin to acquire the image.

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

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

# SECTION 7 - 7 of 8

{10}------------------------------------------------

The materials of the detector which contact operators' skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device.

- 3) Nonclinical Considerations:
The non-clinical studies have been performed and the results have shown that the Mars1417V-PSI wireless digital X-ray flat panel detector is substantially equivalent to the predicate devices on the Market (ViZion DR+Wireless, K152279 ): Detective quantum efficiency (DQE), Quantum limited performance, Modulation transfer function (MTF), Effects of aliasing, Sensitivity linearity, Lag, Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of device characteristics with time, Uniformity of device characteristic, Noise power spectrum(NPS), Spatial resolution, Image Acquisition time, & Black level.

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 the 83 test cases and complies the intended design specification.

- 4) Clinical Consideration:
A concurrence study of 30 clinical images was conducted to compare the performance of the Mars1417V-PSI to that of the predicate device (ViZion DR+Wireless,K152279). Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.

There was no significant difference between the images of the Mars1417V-PSI and those of the predicate device.

#### 10. 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 (Shanghai) Ltd. Concludes that iRay Mars1417V-PSI Wireless Digital Flat Panel Detectors is substantially equivalent to predicate device with regards to safety and effectiveness.

## SECTION 7-8 of 8