Mars 17 17XF-CSI 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 Description

Mars1717XF-CSI 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 (Thin Film Transistor)/PD (Photo Diode) image sensor flat panel of active area: 42.48cm×42.54cm. The sensor plate of Mars1717XF-CSI Wireless Digital Flat Panel Detector 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 user interface. The major function of the Mars1717XF-CSI 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 X-ray imaging with the DR system software.

AI/ML Overview

The provided text describes the iRay Technology Taicang Ltd. "Wireless Digital Flat Panel Detector" (Mars1717XF-CSI) and its substantial equivalence to a predicate device (Mars1417XF-CSI, K182551). The document is a 510(k) summary, which focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving independent effectiveness through extensive clinical studies.

Therefore, the study supporting the device's acceptance criteria primarily relies on non-clinical tests demonstrating substantial equivalence to a predicate device, not a standalone clinical effectiveness study with human readers or AI performance metrics.

Here's a breakdown based on your request, with the understanding that the "study" referred to is a substantial equivalence comparison:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in the traditional sense of performance targets for an AI algorithm. Instead, it compares the proposed device's characteristics and performance metrics to its predicate device to demonstrate substantial equivalence.

Acceptance Criteria (Proxy: Predicate Device Performance)	Proposed Device Performance (Mars1717XF-CSI)
Intended Use: Digital imaging solution for general radiographic diagnosis of human anatomy, replacing film/screen systems in general-purpose diagnostic procedures (excluding mammography or dental).	Same, additionally excludes pediatric, pregnant women, and fluoroscopy. Applicable to usual body parts for adults.
X-Ray Absorber (Scintillator): CsI	Same (CsI)
Installation Type: Wireless, Portable	Same (Wireless, Portable)
Readout Mechanism: Thin Film Transistor	Same (Thin Film Transistor)
Image Matrix Size: 2336 × 2836 pixels	2832 × 2836 pixels (Slight difference due to panel dimension change, considered equivalent)
Pixel Pitch: 150μm	Same (150μm)
ADC Digitization: 16 bit	Same (16 bit)
Effective Imaging Area: 350.4 mm × 425.4 mm	424.8 mm × 425.4 mm (Larger, but considered equivalent as the change is in panel dimension)
Spatial Resolution: Min. 3.3 lp/mm	Same (Min. 3.3 lp/mm)
Modulation Transfer Function (MTF) (0.5 at 1 lp/mm): 0.5 at 1 lp/mm	0.49 at 1 lp/mm (Very close, considered equivalent)
Detective Quantum Efficiency (DQE) (RQA5, 2.5µGy): 0.37 at 1 lp/mm	0.40 at 1 lp/mm (Slightly better, considered equivalent)
Power Consumption: Max. 19W	Max. 20W (Very close, considered equivalent)
Communications (Wireless functionality): IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz)	Same (IEEE 802.11a/b/g/n)
Imaging protect Plate: Carbon Fiber Plate	Same (Carbon Fiber Plate)
Cooling: Air cooling	Same (Air cooling)
Dimensions: 384 mm × 460 mm × 15 mm	460 mm × 460 mm × 15 mm (Larger, but considered a dimension change)
Operation Temperature: +5 ~ +30°C	Same (+5 ~ +30°C)
Operation Humidity: 10 ~ 80% (Non-Condensing)	Same (10 ~ 80% (Non-Condensing))
Operation Atmospheric pressure: 70 ~ 106 kPa	Same (70 ~ 106 kPa)
Operation Altitude: Max. 3000 meters	Same (Max. 3000 meters)
Storage & Transportation Temperature: -20 ~ +50°C	Same (-20 ~ +50°C)
Storage & Transportation Humidity: 10 ~ 90% (Non-Condensing)	Same (10 ~ 90% (Non-Condensing))
Storage & Transportation Atmospheric pressure: 70 ~ 106 kPa	Same (70 ~ 106 kPa)
Software: iRay SDK (include iDetector) supplies API interface for DR system manufacturers.	Same
Electrical Safety and EMC: Compliance with IEC/ES 60601-1 and IEC/EN 60601-1-2.	All test results meet standard requirements.
Biological Evaluation: Materials contacting operators' skin evaluated with ISO 10993-1.	Evaluation results and test results assured safety same as the predicate device.
Image Quality (non-clinical): No significant difference in images between devices.	No significant difference reported from non-clinical studies.

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific "test sets" of data as in an AI performance study comparing to a ground truth. Instead, the "test" primarily involved non-clinical performance testing of the device itself (electrical, mechanical, environmental, biological, and technical specifications) and a comparison to the predicate device's established performance.

Sample Size: Not specified for image evaluation, as it's not a clinical study on a patient cohort. The "non-clinical studies" refer to technical performance evaluations.
Data Provenance: Not applicable in the context of patient data provenance, as this is a device performance evaluation, not a clinical study on images. The studies were non-clinical tests performed by the manufacturer (iRay Technology Taicang Ltd. in China).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth here is the technical specifications and performance of the predicate device, against which the proposed device was compared. There was no "ground truth" derived from human experts interpreting images for diagnostic accuracy in this submission for the purpose of a clinical evaluation of the device's diagnostic performance. The submission claims that "There was no significant difference between the images of the Mars1717XF-CSI and those of the predicate device," but this is a statement summarizing non-clinical evaluation findings rather than a detailed expert-driven image review.

4. Adjudication Method for the Test Set

Not applicable, as there was no expert review of images for diagnostic purposes described as a "test set" with adjudication. The evaluation focused on technical specifications and substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This submission is for a conventional digital X-ray flat panel detector, not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted or mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a hardware device (flat panel detector), not a standalone AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence submission is primarily the technical and performance characteristics of the legally marketed predicate device (Mars1417XF-CSI, K182551), as well as established international standards for medical electrical equipment (e.g., IEC/ES 60601-1, IEC/EN 60601-1-2, ISO 10993-1). The new device's specifications and test results were compared to these benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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. % Meng Li Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA

Re: K183713

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 1, 2018 Received: December 10, 2018

Dear Meng Li:

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 mav, 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 avare 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.

January 9, 2019

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D. O'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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K183713

Device Name Wireless Digital Flat Panel Detector

Indications for Use (Describe)

We understand the Agency has become aware of situations where solid state detectors inserted into radiographic systems adversely impacted device performance due to improper integration (reference:http://www.fda.gov/downloads/ MedicalDevices/ResourcesforYou/Industry/UCM385149.pdf ).

Below is a summary of the information from the Mars1717XF-CSI user manuals covering key electromechanical and computer requirements needed for X-ray system interface and integration.

Mechanical interface requirements.
Computer requirements
Data communication interface requirements
Electrical power requirements
X-ray trigger interface requirements

Neither the Mars 1717XF-CSI detector nor its software act as an X-ray generator controller, and therefore, the device is not subject to Electronic Product Radiation Control (EPRC) performance standards and reporting requirements.

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

[X] 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 (7/17)

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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 1st, 2018

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 215434
Contact Person:	Meng Li
Phone:	0512-53690872
Fax:	0512-53690872
Email:	meng.li@iraygroup.com

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

510(k) Number:	K183713
Trade Name:	Wireless Digital Flat Panel Detector
Common Name:	Solid State X-Ray Imager
Model Name:	Mars1717XF-CSI
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 Devices(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:	Mars1417XF-CSI
Product Code:	MQB
Classification Name:	Stationary X-Ray System
FDA 510 (k) #:	K182551

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

The sensor plate of Mars1717XF-CSI Wireless Digital Flat Panel Detector is directdeposited 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 user interface.

The major function of the Mars1717XF-CSI 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 X-ray imaging with the DR system software.

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

6.1. Intended Use

Mars1717XF-CSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human

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anatomy. It is intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. This device is not intended for mammography, dental applications, pediatric, pregnant women and fluoroscopy.

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

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

Item	Predicate Device:Wireless Digital Flat PanelDetector	ProposedDevice:WirelessDigital FlatPanel Detector
	510(K)Number	K182551	To be assigned
		Intended Use	The Mars1417XF-CSI WirelessDigital Flat Panel Detector isindicated for digital imagingsolution designed for providinggeneral radiographic system inall general purpose diagnosticprocedures.
	Item	Predicate Device:Wireless Digital Flat PanelDetector	ProposedDevice:WirelessDigital FlatPanel Detector
Indications for Use	Mars1417XF-CSI WirelessDigital Flat Panel Detector isindicated for digital imagingsolution designed for providinggeneral radiographic diagnosisof human anatomy. It is intendedto replace radiographicfilm/screen systems in allgeneral-purpose diagnosticprocedures. This device is notintended for mammography ordental applications.We understand the Agency hasbecome aware of situationswhere solid state detectorsinserted into radiographic	, dentalapplications,pediatric,pregnantwomen andfluoroscopy.Same withMars1417XF-CSI,additionally, Intheconsiderationof patient size(i.e., height,weight, bodypart thickness)and usabledose range, thedetector couldbe used forgeneral X raydiagnosis of
	systems adversely impacteddevice performance due to	usual body partfor adult.
Item	Predicate Device:Wireless Digital Flat PanelDetector	ProposedDevice:WirelessDigital FlatPanel Detector
	improper integration(reference:http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM385149.pdf).Below is a summary of theinformation from theMars1417XF-CSI user manualscovering key electromechanicaland computer requirementsneeded for X-ray systeminterface and integration.1. Mechanical interfacerequirements.2. Computer requirements3. Data communication interfacerequirements4. Electrical power requirements5. X-ray trigger interfacerequirementsNeither the Mars1417XF-CSIdetector nor its software act asan X-ray generator controller,and therefore, the
Item	Predicate Device:	Proposed Device:
	Wireless Digital Flat PanelDetector	WirelessDigital FlatPanel Detector
	device is not subject toElectronic Product RadiationControl (EPRC) performancestandards and reportingrequirements.
ClassificationName	Stationary X-ray system	Same
Product Code	MQB	Same
Regulation Number	21 CFR 892.1680	Same
Panel:	Radiology	Same
Classification:	II	Same
X-Ray Absorber(Scintillator):	CsI	Same
Installation Type:	Wireless, Portable	Same
Readout Mechanism:	Thin Film Transistor	Same
Image Matrix Size:	2336 × 2836 pixels	2832× 2836 pixels
Pixel Pitch:	150μm	Same
ADC Digitization	16 bit	Same
Effective Imaging Area:	350.4 mm × 425.4 mm	424.8 mm × 425.4 mm
Spatial Resolution:	Min. 3.3lp/mm	Same
ModulationTransferFunction	0.5 at 1 lp/mm	0.49 at 1 lp/mm
Item(MTF)	Predicate Device:Wireless Digital Flat PanelDetector	ProposedDevice:WirelessDigital FlatPanel Detector
DetectiveQuantumEfficiency(DQE)(RQA5, 2.5µGy)	0.37 at 1 lp/mm	0.40 at 1lp/mm
Power Consumption:	Max. 19W	Max. 20W
Communications:(Wireless functionality)	Wireless: IEEE 802.11a/b/g/n(2.4 GHz / 5 GHz)	Same
Imaging protect Plate:	Carbon Fiber Plate	Same
Cooling:	Air cooling	Same
Dimensions:	384 mm × 460 mm × 15 mm	460 mm × 460 mm × 15 mm
Operation:	Temperature: +5 ~ +30°CHumidity: 10 ~ 80%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPaAltitude: Max. 3000 meters	Same
Storage andTransportation:( detector )	Temperature: -20 ~ +50°CHumidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPa	Same
Item	Predicate Device:Wireless Digital Flat PanelDetector	ProposedDevice:WirelessDigital FlatPanel Detector
Software	Altitude: Max. 3000 metersiRay SDK(include iDetector) isintend to supply API interfacefor DR system manufacturers.DR system manufacturer controlthe detector by SDK interface.SDK is not intend to use directlyby other users beside DR systemmanufacturers.	Same
	Utilized FDA guidancedocuments	1. Guidance for the Submissionof 510(k)'s for Solid StateX-ray Imaging Devices;2. The 510(k) Program:Evaluating SubstantialEquivalence in PremarketNotifications[510(k)];3. Content of PremarketSubmissions forManagement ofCybersecurity in MedicalDevices;4. Radio Frequency WirelessTechnology in MedicalDevices.	Same

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

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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 still having any questions regarding the compatibility issue for other generators, please contact the distributor or iRay's service office.

1. Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1717XF-CSI detector connected via wireless communication.

Operating System:	Windows XP/7 32/64bit
CPU:	Intel Core i5 3.6G
Memory:	8G DDR3
Hard Disk:	640 G
LAN Card:	Intel Pro EXP9301CT PRO
	Gigabit Network Adapter with PCIe interface

3) X-ray exposure mode

The AED trigger module is a unit can connect X-ray signal in the Mars1717XF-CSI. 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)

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iRay Technology Taicang Ltd.

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.

1. Biological Evaluation:
  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.
1. Non-clinical Considerations:
  The only modification from the predicate device to Mars1717XF-CSI is the panel dimension, related to Amorphous Silicon (A-Si) panel size and structure size design. 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 (Mars1417XF-CSI, K182551).
1. Clinical Consideration:
  The only modification from the predicate device to Mars1717XF-CSI is the panel dimension, related to Amorphous Silicon (a-Si) panel size and structure size design. 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, which is described details in '009 Substantial Equivalence Discussion' in this submission.

There was no significant difference between the images of the Mars1717XF-CSI and those of the predicate device.

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

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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 iRay Mars1717XF-CSI Wireless Digital Flat Panel Detectors 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.