Wireless 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.

Device Description

Mars1013X Wireless Digital Flat Panel Detector (Hereinafter referred to as Mars1013X) is the 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: 33.18cm×25.28cm. The sensor plate of Mars1013X is direct-deposited with CsI(Cesium Iodide) 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 Mars1013X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. 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. iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.

AI/ML Overview

The provided text is a 510(k) summary for the iRay Technology Taicang Ltd. Wireless Digital Flat Panel Detector (Mars1013X). It describes the device, its intended use, and its comparison to predicate devices to demonstrate substantial equivalence.

However, the document does NOT contain information about specific acceptance criteria related to a study proving the device meets those criteria in the context of AI/algorithm performance. It primarily focuses on the device's physical and technical specifications, electrical safety, biological evaluation, and comparison to predicate devices, but not on clinical performance metrics that would typically be established for an AI-powered diagnostic device.

The provided text describes a "Wireless Digital Flat Panel Detector", which is a hardware component for X-ray imaging, not an AI or algorithmic diagnostic device. Therefore, the questions related to AI-specific acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable to the information contained in this document.

The document states:

"Mars1013X Wireless Digital Flat Panel Detector is the 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: 33.18cm×25.28cm"
"The major function of the Mars1013X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging."

The performance metrics discussed (Spatial Resolution, MTF, DQE) are physical imaging characteristics of the detector itself, not diagnostic performance of an AI analyzing the images.

Therefore, it is not possible to extract the requested information regarding acceptance criteria and a study proving an AI device's performance from the provided text. The document pertains to the clearance of an X-ray detector, not an AI diagnostic algorithm.

Summary

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April 1, 2022

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

iRay Technology Taicang Ltd. % Junjie Oian Registration & Regulation Affairs Engineer No. 33 Xinggang Rd. Taicang Port Economic Technological Development Zone Taicang, Jiangsu 215434 CHINA

Re: K220668

Trade/Device Name: Wireless Digital Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: November 11, 2021 Received: March 7, 2022

Dear Mr. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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

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Indications for Use

510(k) Number (if known) K220668

Device Name Wireless Digital Flat Panel Detector

Indications for Use (Describe)

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)
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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

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

November 11, 2021

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 andTechnological Development Zone, Jiangsu, China 21543-
Contact Person:	Junjie Qian
Phone:	0512-53690872
Fax:	0512-53690872
Email:	junjie.qian@iraygroup.com

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

Trade Name:	Wireless Digital Flat Panel Detector
Common Name:	Solid State X-Ray Imager
Model Name:	Mars1013X
Classification Name:	Stationary X-Ray System
Product Code:	MQB
Regulation Number:	21 CFR 892.1680
Device Class:	Class II

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

The identification predicates within this submission are as follows:

Manufacturer:	iRay Technology Taicang Ltd.
Trade Name:	Wireless Digital Flat Panel Detector
Model Name:	Mars1417X
Product Code:	MQB
Classification Name:	Stationary X-Ray System
Regulation Number:	21 CFR 892.1680
Device Class:	Class II
FDA 510 (k) #:	K210316

5. Identification of Reference Device(s) [21 CFR 807.92(a)(3)[

Manufacturer:	iRay Technology Taicang Ltd.
Trade Name:	Wireless Digital Flat Panel Detector
Model Name:	Mars1717XF-CSI
Product Code:	MQB
Classification Name:	Stationary X-Ray System
Regulation Number:	21 CFR 892.1680
Device Class:	Class II
FDA 510 (k) #:	K183713

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

The sensor plate of Mars1013X is direct-deposited with CsI(Cesium Iodide) scintillator to achieve the conversion from X-ray to visible photon. The visible photons are

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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 Mars1013X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. 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.

iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.

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

7.1. Indications for use

Mars1013X wireless 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

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

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Item	Predicate Device:Mars1417XWireless Digital FlatPanel Detector	Proposed Device:Mars1013XWireless Digital FlatPanel Detector	Reference Device:Mars1717XF-CSIWireless DigitalFlat Panel Detector
510(K) Number	K210316	K220668	K183713
Intended Use	Mars1417X WirelessDigital Flat PanelDetector is indicatedfor digital imagingsolution designed forproviding generalradiographic system inall general-purposediagnostic procedures.	Same	Same
Indications forUse	Mars1417X wirelessdigital flat paneldetector is indicatedfor digital imagingsolutions designed toprovide generalradiographic diagnosisfor human anatomyincluding both adultand pediatric patients.It is intended toreplace film/screensystems in all general-purpose diagnostic	Same	Same
	Predicate Device:	Proposed Device:	Reference Device:
Item	Mars1417XWireless Digital FlatPanel Detector	Mars1013XWireless Digital FlatPanel Detector	Mars1717XF-CSIWireless DigitalFlat Panel Detector
	procedures. Thedevice is not intendedfor mammography ordental applications.


ClassificationName	Stationary X-raysystem	Same	Same
Product Code	MQB	Same	Same
RegulationNumber	21 CFR 892.1680	Same	Same
Panel:	Radiology	Same	Same
Classification:	II	Same	Same
X-Ray Absorber(Scintillator):	CsI	Same	Same
Installation Type:	Wireless, Portable	same	Same
ReadoutMechanism:	Thin Film Transistor	Same	Same
Image MatrixSize:	3500 × 4300 pixels	3318 × 2528 pixels	2832 × 2836 pixels
Pixel Size:	100μm	100μm	150μm
ADC Digitization	16 bit	Same	Same
Effective ImagingArea:	350.0 mm × 430.0 mm	331.8 mm × 252.8 mm	424.8 mm × 425.4 mm
SpatialResolution:	Min. 4.3lp/mm	Min. 4.3lp/mm	Min. 3.3lp/mm
Item	Predicate Device:Mars1417XWireless Digital FlatPanel Detector	Proposed Device:Mars1013XWireless Digital FlatPanel Detector	Reference Device:Mars1717XF-CSIWireless Digital Flat Panel Detector
ModulationTransferFunction(MTF)	0.65 at 1 lp/mm	Min. 0.60 at 1 lp/mm	0.49 at 1 lp/mm
DetectiveQuantumEfficiency(DQE)	0.54 at 1 lp/mm(RQA5, 2.5µGy)	Min. 0.43 at 1 lp/mm(RQA5, 2.5µGy)	0.40 at 1 lp/mm(RQA5, 2.5µGy)
PowerConsumption:	Max. 19W	Max. 18W	Max. 20W
Communications:(Wirelessfunctionality)	a) Wired (only forservice) : GigabitEthernet(1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac(2.4 GHz / 5 GHz)	a) Wired (only forservice) : GigabitEthernet(1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac(2.4 GHz / 5 GHz)	Wireless: IEEE802.11a/b/g/n(2.4 GHz / 5 GHz)
Imaging protectPlate:	Carbon Fiber Plate	Same	Same
Cooling:	Air cooling	Same	Same
Dimensions:	384 mm × 460 mm ×15 mm	362.1 mm × 269.2 mm× 15.5 mm	460 mm × 460mm× 15 mm
	Predicate Device:	Proposed Device:	Reference Device:
Item	Mars1417XWireless Digital Flat	Mars1013XWireless Digital Flat	Mars1717XF-CSIWireless DigitalFlat Panel Detector
	Panel Detector	Panel Detector
Detector IP grade	IP56	IPX5	IPX4
	adapter port input :	adapter port input :	adapter port input :
	24Vdc 1.46A	24Vdc 0.75A	24Vdc 1.25A
Power input	Battery port input:	Battery port input:	Battery port input:
	11.55Vdc 1.6A	11.55Vdc 1.6A	7.6Vdc 3500mAh
Surface pressure	Uniform load: 300 kgover the whole area ofthe surface;Local load: 150 kgon an area 4 cmdiameter of center	Uniform load: 150 kgover the whole area ofthe surface;Local load: 100 kg onan area 4 cm diameterof center	Uniform load:150 kg over thewhole area of thesurface;Local load: 100kg on an area 4 cmdiameter of center
Operation:	Temperature: +10 ~+35°CHumidity: 5 ~ 90%(Non-Condensing)Atmospheric pressure:70 ~ 106 kPaAltitude: Max. 3000meters	Temperature: +10 ~+35°CHumidity: 5 ~ 90%(Non-Condensing)Atmospheric pressure:70 ~ 106 kPaAltitude: Max. 3000meters	Temperature: +5 ~+30°CHumidity: 10 ~80%(Non-Condensing)Atmosphericpressure: 70 ~ 106kPaAltitude: Max.3000 meters
Item	Predicate Device:	Proposed Device:	Reference Device:
	Mars1417XWireless Digital FlatPanel Detector	Mars1013XWireless Digital FlatPanel Detector	Mars1717XF-CSIWireless DigitalFlat Panel Detector
Storage andTransportation:(detector)	Temperature: -20 ~ +55°CHumidity: 5 ~ 95%(Non-Condensing)Atmospheric pressure: 60 ~ 106 kPaAltitude: Max. 3000 meters	Temperature: -20 ~ +55°CHumidity: 5 ~ 95%(Non-Condensing)Atmospheric pressure: 60 ~ 106 kPaAltitude: Max. 3000 meters	Temperature: -20 ~ +50°CHumidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPaAltitude: Max. 3000 meters
Software	SDK(include iDetector) is intend tosupply API interface for DR systemmanufacturers. DR system manufacturercontrol the detector by SDK interface. SDK isnot intend to use directly by other usersbeside DR system manufacturers.	Same	Same

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

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9. System requirements to operate with other radiographic system components

9.1. 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 the distributor or iRay's service office.

9.2. Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1013X connected via wireless communication.

Operating System:	Windows 10, 32/64bit
CPU:	Intel Core i7 3.6G
Memory:	8G DDR3
Hard Disk:	640 G
LAN Card:	Intel Pro EXP9301CT PROGigabit Network Adapter with PCIe interface

9.3. X-ray exposure mode

The AED trigger module is a unit can connect X-ray signal in the Mars1013X. Once there is X-ray generator exposure exist, the AED 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.

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

10.1. Electrical Safety and EMC testing:

Electrical, mechanical, environmental safety according to IEC/ES 60601-1 and IEC 60601-2-54 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.

10.2. Biological Evaluation:

The materials of the detector which contact operators' or patient's 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.

Non-clinical Considerations: 10.3.

One main modification from the predicate device is Amorphous Silicon (a-Si) panel size design, related to Amorphous Silicon (A-Si) panel size. Another main modification is structure design with different IP grade and different surface pressure performance.

The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1417X, K210316).

10.4. Clinical Consideration:

Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software 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', clinical consideration may not necessary for changes in the dimensions of the image receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence.

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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 Mars1013X is substantially equivalent to predicate device with regards to safety and effectiveness.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
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.(b)
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.