Mars1717X 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

Mars1717X Wireless Digital Flat Panel Detectors (Hereinafter referred to as Mars1717X) 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: 42.67cm×42.67cm.

The sensor plate of Mars1717X 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 Mars1717X 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 document is a 510(k) Summary for the Mars1717X Wireless Digital Flat Panel Detector by iRay Technology Taicang Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device (Mars1717V-VSI, K201043) rather than detailing a specific study to prove the device meets acceptance criteria regarding clinical performance.

The document states that clinical consideration may not be necessary for changes in image receptor dimensions if non-clinical information is sufficient to support substantial equivalence. This implies that a dedicated clinical study to evaluate the device against specific performance acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity for detecting conditions) was likely not performed or considered necessary by the FDA for this 510(k) clearance due to the nature of the device as an X-ray detector and the comparison to a predicate.

Therefore, many of the requested details about a study proving device performance against acceptance criteria for diagnostic capability cannot be extracted from this document, as such a study does not appear to be the basis for this 510(k) clearance. The "acceptance criteria and reported device performance" primarily relate to technical specifications and equivalence.

However, I can extract information regarding technical performance metrics and how they compare between the proposed device and the predicate. These comparisons serve as the "evidence" for substantial equivalence.

Here's the breakdown based on the provided text, focusing on the technical and non-clinical aspects:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the format of a clinical performance study. Instead, it compares the technical specifications and performance characteristics of the proposed device (Mars1717X) to its predicate (Mars1717V-VSI). The "acceptance criteria" can be inferred as being at least equivalent to or better than the predicate device for relevant technical specifications to demonstrate substantial equivalence.

Characteristic / "Acceptance Criteria"	Predicate Device (Mars1717V-VSI, K201043)	Proposed Device (Mars1717X, K210314)	"Met Acceptance Criteria" (Inferred)	Notes
Indications for Use	Same	Same	Yes	Crucial for demonstrating substantial equivalence.
Image Matrix Size	3072 x 3072 pixels	4267 x 4267 pixels	Improved	Higher resolution.
Pixel Size	139 µm	100 µm	Improved	Smaller pixel size generally means higher spatial resolution.
ADC Digitization	16 bit	Same	Yes	Maintained high data depth.
Effective Imaging Area	427 mm x 427 mm	426.7 mm x 426.7 mm	Same (regarded as)	Minor difference, considered substantially equivalent.
Spatial Resolution	Min. 3.6 lp/mm	Min. 4.3 lp/mm	Improved	Higher spatial resolution.
Detective Quantum Efficiency (DQE)	0.40 at 1 lp/mm (RQA5, 2.5µGy)	0.54 at 1 lp/mm (RQA5, 2.5µGy)	Improved	Higher DQE indicates better image quality for a given dose.
Power Consumption	Max. 30W	Max. 19W	Improved	Lower power consumption.
Communications	Wired (Gigabit Ethernet), Wireless (IEEE 802.11a/b/g/n/ac)	Same	Yes	Maintained connectivity options.
Imaging Protect Plate	Carbon Fiber Plate	Same	Yes	Maintained material.
Cooling	Air cooling	Same	Yes	Maintained cooling method.
Dimensions	460 mm x 460 mm x 15.3 mm	460 mm x 460 mm x 15 mm	Improved	Slightly thinner.
Detector IP grade	IPX1	IP56	Improved	Higher protection against ingress (solids and liquids), making it more robust.
Surface Pressure (Uniform load)	150 kg over whole area	300 kg over whole area	Improved	Increased durability.
Surface Pressure (Local load)	100 kg on an area 4 cm diameter	150 kg on an area 4 cm diameter	Improved	Increased durability.
Operating Temperature	+5 ~ +35°C	+10 ~ +35°C	Comparable (Slight change)	Still within expected operating range; considered substantially equivalent for clinical use.
Operating Humidity	5 ~ 95% (Non-Condensing)	5 ~ 90% (Non-Condensing)	Comparable (Slight change)	Still within expected operating range; considered substantially equivalent for clinical use.
Storage Temperature	-10 ~ +55°C	-20 ~ +55°C	Improved	Broader storage temperature range.
Battery Model	Battery-KV (10.8V)	Battery-KX (11.55V)	Different (Improved specifications)	New model, likely with improved performance/design, but functionally equivalent.
X-ray Exposure Mode	(Implied AED trigger)	AED trigger module	Same principle	Automatic Exposure Detection (AED) is a common feature and is maintained.
Electrical Safety & EMC	Complies with IEC/ES 60601-1, IEC 60601-1-2	Complies with IEC/ES 60601-1, IEC 60601-1-2	Yes	Standard requirements met for safety.
Biological Evaluation	Complies with ISO 10993-1	Complies with ISO 10993-1	Yes	Materials contacting skin are safe.

Regarding a "study that proves the device meets the acceptance criteria":

For this 510(k) submission, the "study" is a comparative technical performance assessment against a legally marketed predicate device (K201043). The conclusion of substantial equivalence means the device meets the regulatory "acceptance criteria" for market clearance based on this comparison. The non-clinical studies performed were used to demonstrate that changes in panel size, structure, IP grade, and surface pressure do not raise new questions of safety or effectiveness and that the performance is substantially equivalent to or better than the predicate.

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

Sample Size: Not applicable in the context of a clinical test set for diagnostic accuracy, as no such clinical study appears to have been conducted for this 510(k). The "test set" would be the device itself undergoing various engineering and performance tests (e.g., DQE measurements, spatial resolution charts, durability tests). The document does not specify the number of units tested.
Data Provenance: The technical performance data (DQE, spatial resolution, etc.) would be generated from laboratory tests conducted by the manufacturer, iRay Technology Taicang Ltd., in China.

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

Not applicable, as no clinical test set with human diagnostic ground truth was used for this 510(k) clearance based on the provided document.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring expert adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not performed according to this document. The submission focuses on technical equivalence to a predicate X-ray detector, not on the diagnostic effectiveness of human readers using the device with and without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

Yes, the evaluation is inherently a standalone performance assessment of the device itself (the flat panel detector) in terms of its image acquisition capabilities (spatial resolution, DQE, etc.). There is no AI algorithm being evaluated for diagnostic assistance in this context. The device's performance is measured objectively based on physical and technical specifications, independent of human interpretation.

7. Type of Ground Truth Used:

For the technical performance aspects, "ground truth" refers to objective physical measurements and standards. For example:
- Spatial resolution is measured using phantoms or line pair gauges with known patterns.
- DQE is measured according to standardized protocols (e.g., IEC 62220-1) using known X-ray spectra and dose levels.
- Durability (surface pressure, IP rating) is tested against engineering specifications and industry standards.
- Safety (electrical, biological) is assessed against international standards (e.g., IEC 60601-1, ISO 10993-1).

8. Sample Size for the Training Set:

Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense. The "training" in manufacturing would refer to quality control and calibration processes during production.

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

Not applicable, as there is no training set in the context of an AI algorithm.

Summary

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March 2, 2021

Image /page/0/Picture/1 description: The image contains 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 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: K210314

Trade/Device Name: Mars1717X 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: January 13, 2021 Received: February 3, 2021

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 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

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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 (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-device-safety/medical-device-reportingmdr-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/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,

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

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Indications for Use

510(k) Number (if known)

K210314

Device Name Mars1717X 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)

K210314

1. Date Prepared [21 CFR 807.92(a)(1)]
  January 13, 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 215434
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:	Mars1717X Wireless Digital Flat Panel Detector
Common Name:	Solid State X-Ray Imager
Model Name:	Mars1717X
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:	Mars1717V-VSI
Product Code:	MQB
Classification Name:	Stationary X-Ray System
Regulation Number:	21 CFR 892.1680
Device Class:	Class II
FDA 510 (k) #:	K201043

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

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

6.1. Indications for use

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 Xray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.

Item	Predicate Device:Mars1717V-VSI WirelessDigital Flat Panel Detector	Proposed Device:Mars1717X Wireless DigitalFlat Panel Detector
510(K) Number	K201043	K210314
Intended Use	The Mars1717V-VSI WirelessDigital Flat Panel Detector isindicated for digital imagingsolution designed for providinggeneral radiographic system inall general-purpose diagnosticprocedures.	Same
	Predicate Device:	Proposed Device:
Item	Mars1717V-VSI WirelessDigital Flat Panel Detector	Mars1717X Wireless DigitalFlat Panel Detector
Indications forUse	Mars1717V-VSI is indicatedfor digital imaging solutionsdesigned to provide generalradiographic diagnosis forhuman anatomy including bothadult and pediatric patients.They are intended to replacefilm/screen systems in allgeneral-purpose diagnosticprocedures. These two devicesare not intended formammography, dentalapplications.	Mars1717X wireless digital flatpanel detector is indicated fordigital imaging solutionsdesigned to provide generalradiographic diagnosis forhuman anatomy including bothadult and pediatric patients. It isintended to replace film/screensystems in all general-purposediagnostic procedures. Thedevice is not intended formammography or dentalapplications.
ClassificationName	Stationary X-ray system	Same
Product Code	MQB	Same
RegulationNumber	21 CFR 892.1680	Same
Panel:	Radiology	Same
Classification:	II	Same
X-Ray Absorber(Scintillator):	CsI	Same
Installation Type:	Wireless, Portable	Same
ReadoutMechanism:	Thin Film Transistor	Same
	Predicate Device:	Proposed Device:
Item	Mars1717V-VSI WirelessDigital Flat Panel Detector	Mars1717X Wireless DigitalFlat Panel Detector
Image MatrixSize:	$3072 \times 3072$ pixels	$4267 \times 4267$ pixels
Pixel Size:	139μm	100μm
ADC Digitization	16 bit	Same
Effective ImagingArea:	$427mm \times 427 mm$	$426.7 mm \times 426.7mm$can be regarded as same
SpatialResolution:	Min. 3.6lp/mm	Min. 4.3lp/mm
DetectiveQuantumEfficiency(DQE)	0.40 at 1 lp/mm (RQA5,2.5μGy)	0.54 at 1 lp/mm (RQA5,2.5μGy)
PowerConsumption:	Max. 30W	Max. 19W
Communications:(Wirelessfunctionality)	a) Wired (only for service) : GigabitEthernet (1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac (2.4 GHz / 5 GHz)	Same
Imaging protectPlate:	Carbon Fiber Plate	Same
Cooling:	Air cooling	Same
Dimensions:	$460 mm \times 460 mm \times 15.3 mm$	$460 mm \times 460 mm \times 15mm$
Detector IP grade	IPX1	IP56
	Predicate Device:	Proposed Device:
Item	Mars1717V-VSI WirelessDigital Flat Panel Detector	Mars1717X Wireless DigitalFlat Panel Detector
Surface pressure	Uniform load: 150 kg over thewhole area of the surface;Local load: 100 kg on an area 4 cm diameter of center	Uniform load: 300 kg over thewhole area of the surface;Local load: 150 kg on an area 4 cm diameter of center
	Operation:	Temperature: +5 ~ +35°CHumidity: 5 ~ 95%(Non-Condensing)Atmospheric pressure: 55 ~ 106 kPaAltitude: Max. 3000 meters	Temperature: +10 ~ +35°CHumidity: 5 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPaAltitude: Max. 3000 meters
		Storage andTransportation:(detector)	Temperature: -10 ~ +55°CHumidity: 5 ~ 95%(Non-Condensing)Atmospheric pressure: 55 ~ 106 kPaAltitude: Max. 3000 meters	Temperature: -20 ~ +55°CHumidity: 5 ~ 95%(Non-Condensing)Atmospheric pressure: 60 ~ 106 kPaAltitude: Max. 3000 meters
			Software	iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers.DR system manufacturer control the detector by SDK interface. SDK is not intend to use directly by other users beside DR system manufacturers.
	Predicate Device:		Proposed Device:
Item	Mars1717V-VSI WirelessDigital Flat Panel Detector	Mars1717X Wireless DigitalFlat Panel Detector
Utilized FDAguidancedocuments	1. Guidance for theSubmission of 510(k)'s forSolid State X-ray ImagingDevices;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.5. Guidance for “PremarketAssessment of PediatricMedical Devices”;6. Guidance for “PediatricInformation for X-rayImaging Device PremarketNotifications”.	Additionally:1. The Special 510(k)Program;2. Design Control GuidanceFor Medical DeviceManufacturers;3. Appropriate Use ofVoluntary ConsensusStandards in PremarketSubmissions for MedicalDevices.
Battery	Model: Battery-KVRated Voltage:10.8V	Model: Battery-KXRated Voltage:11.55V

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 you have 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: Mars1717X connected via wireless communication.

Operating System:	Windows XP/7/8/10, 32/64bit
CPU:	Intel Core i7 3.6G
Memory:	4G DDR3
Hard Disk:	640 G
LAN Card:	Intel Pro EXP9301CT PROGigabit Network Adapter with PCIe interface

3) X-ray exposure mode

The AED trigger module is a unit can connect X-ray signal in the Mars1717X. 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.

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

1. Electrical Safety and EMC testing:

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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.

1. 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.
1. Non-clinical Considerations:
  One main modification from the predicate device is Amorphous Silicon (a-Si) panel size design, related to Amorphous Silicon (A-Si) panel size. Another modification is structure design with thinner panel thickness, higher IP grade and 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-clinical consideration of predicate devices on the Market (Mars1717V-VSI, K201043).

1. 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.

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

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Co., Ltd. concludes that Mars1717X 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.

Re: K210314

Dear Meng Li:

Indications for Use

K210314

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

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

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

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

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

6.1. Indications for use

6.2. Suitable patient

6.3. Processing of input and output

8. System requirements to operate with other radiographic system components

3) X-ray exposure mode

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

8 of 10

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

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§ 892.1680 Stationary x-ray system.

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