1717FCC is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

Device Description

1717FCC is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to amorphous silicon (a-Si) / Indium Gallium Zinc Oxide (IGZO) on TFT sensor. This device is connected to the user PC via wired LAN (ethernet cable) and it needs to be integrated with a radiographic imaging system. It does not operate as an X-ray generator controller but can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW(Xmaru RF) for a radiographic diagnosis and analysis.

AI/ML Overview

The provided text describes a 510(k) summary for the Rayence 1717FCC Digital Flat Panel X-Ray Detector, claiming substantial equivalence to predicate devices (1717SCC, K171420) and a reference device (DRF 4343, K080859). The performance claims primarily revolve around demonstrating equivalent or better image quality and technical specifications compared to these predicate devices, rather than establishing acceptance criteria against a specific clinical performance threshold.

Therefore, the typical structure for answering questions about acceptance criteria and clinical study results for a new AI/CAD device (which usually involves specific metrics like sensitivity, specificity, AUC, human reader improvement, etc.) is not directly applicable to this document. This submission is for a hardware device (a digital X-ray detector), not an AI algorithm, and the primary method of demonstrating "acceptance" is through showing substantial equivalence to existing hardware rather than meeting specific clinical performance metrics.

However, I can interpret the request in the context of this 510(k) submission for a hardware device and extract relevant information to address the spirit of your questions as much as possible.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this hardware device, "acceptance criteria" are based on demonstrating equivalent or superior technical performance and image quality compared to a legally marketed predicate device, rather than diagnostic accuracy metrics.

Characteristic	Acceptance Criteria (Equivalent/Better than Predicate/Reference)	Reported Device Performance (1717FCC)	Relationship to "Acceptance"
Indications for Use	Same as predicate (general radiographic system, not mammography)	"1717FCC is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to... replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography."	Met (Same) - The core "intended use" is identical to the predicate, forming a foundational aspect of substantial equivalence.
Detector Type	Similar to predicate (Amorphous Silicon (a-Si) TFT)	Amorphous Silicon (a-Si) TFT + PIN type photodiode; IGZO TFT + PIN type photodiode (option)	Met (Similar, with enhancement) - The change to IGZO TFT is noted as an option, but the fundamental technology (flat panel, TFT) is similar. The document doesn't indicate this as a failing point; rather, an innovation.
Scintillator	Same as predicate (CsI:Tl)	CsI:Tl	Met (Same) - Explicitly stated as the same, which is a key component for image generation.
Imaging Area	Similar to predicate (17 x 17 inches)	17 x 17 inches	Met (Same) - Physical size is the same.
Pixel Matrix/Pitch	Similar pixel matrix/pitch to predicate (e.g., 140 μm)	140 type: 3000 x 3000 (Full resolution), 140 μm / 280 μm/ 420 μm/ 560 μm	Met (Similar, with enhancements/options) - While offering different pixel options (280/420/560 μm, and associated binning), the 140 μm is comparable to the predicate. The document states "The pixel matrix and pixel pitch sizes are different imaging areas but the differences do not raise new concerns for the safety and effectiveness of the subject device."
A/D Conversion	Same as predicate (14 bit / 16 bit)	14 / 16 bit	Met (Same)
MTF (Image Sharpness)	Equivalent or better than predicate	a-Si TFT: 1.0 lp/mm, Typ. 0.535; 2.0 lp/mm, Typ. 0.220; 3.0 lp/mm, Typ. 0.099; 3.5 lp/mm, Typ. 0.073. IGZO TFT: Comparison to predicate not directly given for IGZO, but implied as strong performance.	Met (Equivalent or Better) - "1717FCC demonstrated equivalent or better performance in terms of MTF... compared to 1717SCC, the predicate device, at all spatial frequencies."
DQE (Image Quality/Dose Efficiency)	Equivalent or better than predicate	a-Si TFT: Typ. 0.751 (at 0 lp/mm). IGZO TFT: Typ. 0.766 (at 0 lp/mm). Predicate 1717SCC was Typ. 0.740 (at 0 lp/mm).	Met (Equivalent or Better) - "1717FCC demonstrated equivalent or better performance in terms of... DQE as well as NPS compared to 1717SCC, the predicate device, at all spatial frequencies."
NPS (Noise Power Spectrum)	Equivalent or better than predicate	(Specific values not detailed, but comparison mentioned)	Met (Equivalent or Better) - "1717FCC demonstrated equivalent or better performance in terms of... NPS compared to 1717SCC, the predicate device, at all spatial frequencies."
Preview Time	Same as predicate (<2 seconds)	<2 seconds	Met (Same)
Data Output	Same as predicate (RAW, convertible to DICOM 3.0)	RAW; "The RAW files are convertible into DICOM 3.0 by console S/W"	Met (Same)
Frame Rate	Equivalent or better than reference device	GigE: 6@ (1x1), 25@ (2x2), 45@ (3x3), 60@ (4x4). Camera Link: 9@ (1x1), 30@ (2x2), 45@ (3x3), 60@ (4x4). 5GigE: 15@ (1x1), 30@ (2x2), 45@ (3x3), 60@ (4x4).	Met (Better) - "The frame rate and image resolution for 1717 FCC, the subject device, perform better than the specification of the reference device, DRF 4343 (K080859)..."
Image Resolution	Equivalent or better than reference device	Up to 3.5 lp/mm (Reference: Up to 3.4 lp/mm)	Met (Better) - "The frame rate and image resolution for 1717 FCC, the subject device, perform better than the specification of the reference device, DRF 4343 (K080859)..."

Summary of the "Study" (Performance Testing):

The "study" described is a technical performance comparison and a qualitative review of radiographic images, not a clinical trial involving patient outcomes or diagnostic accuracy per se.

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

Test Set Sample Size: Not explicitly quantified as a number of images or patients. The document states a "broad review of plain radiographic images taken with 1717FCC and 1717SCC_140μm" was performed. This suggests a qualitative comparison rather than a statistically powered quantitative diagnostic study.
Data Provenance: Not specified regarding country of origin. The study appears to be retrospective in the sense that existing images from the predicate device were compared to images from the new device. It's not a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Number of Experts: Not specified. The phrase "broad review" suggests clinical input, but no specific number of reviewers is given.
Qualifications of Experts: Not specified. It's implied that the review was done by qualified personnel ("There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion."), likely radiologists or clinical specialists experienced in interpreting plain radiographic images.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/not specified. Given the nature of a "broad review" for qualitative comparison (rather than a quantitative diagnostic accuracy study with ground truth establishment), formal adjudication methods (like 2+1, 3+1) are not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

Was it done?: No. This submission does not describe an MRMC study comparing human readers with and without AI assistance. The device is a digital X-ray detector, not an AI diagnostic algorithm for human assistance. The comparison is between the new detector and existing detectors.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Was it done?: Not applicable in the context of an AI algorithm. The performance testing was "standalone" in a sense, as it focused on the intrinsic technical characteristics of the detector itself (MTF, DQE, NPS, frame rate, resolution) through non-clinical laboratory tests, and a qualitative image comparison. It's not an "algorithm" being tested.

7. The Type of Ground Truth Used:

Type of Ground Truth: For the "image quality" comparison, the "ground truth" seems to be a qualitative assessment by unspecified experts that the images from 1717FCC were of "equivalent or better quality" in terms of "spatial and soft tissue contrast resolution" compared to the predicate.
- For the technical performance metrics (MTF, DQE, NPS), the "ground truth" is measured against standardized tests (IEC 62220-1) and compared directly to the measured performance of predicate devices. These are objective engineering measurements.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This document describes a hardware device (X-ray detector), not an AI/machine learning algorithm that requires a training set.

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

Ground Truth Establishment for Training Set: Not applicable, as there is no AI training set for this hardware device.

In conclusion, this 510(k) submission for the Rayence 1717FCC detector demonstrates substantial equivalence based on a comparison of technical specifications, qualitative image review, and objective non-clinical performance metrics (like MTF, DQE, NPS) against predicate and reference hardware devices. It does not involve complex clinical accuracy studies or AI performance metrics as would be seen for a software-based diagnostic AI device.

Summary

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April 28, 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St., Suite 610 HOUSTON TX 77054

Re: K210985

Trade/Device Name: 1717FCC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, JAA Dated: March 26, 2021 Received: April 1, 2021

Dear Mr. Kim:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 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.

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) K210985

Device Name 1717FCC

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 K210985

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510k summary prepared: April 16, 2021

Submitter's Name, address, telephone number, a contact person:

Submitter's Name :	Rayence Co., Ltd.
Submitter's Address:	14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea
Submitter's Telephone:	+82-31-8015-6459
Contact person:	Mr. Kee Dock Kim / RA Team Manager / +82-31-8015-6459
Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
Address:	7505 Fannin St. Ste 610-V111, Houston, TX 77054
Telephone:	+713-467-2607

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

Trade/proprietary name	: 1717FCC
Common Name	: Digital Flat Panel X-ray Detector
Regulation Number	: 21 CFR 892.1680
Regulation Name	: Stationary X-ray System
Regulatory Class	: Class II
Product Code	: MQB, JAA

Primary Predicate Device :

Trade/Device Name	: 1717SCC_127μm and 1717SCC_140μm
Common Name	: Digital Flat Panel X-ray Detector
510(k) Number	: K171420
Regulation Number	: 21 CFR 892.1680
Regulation Name	: Stationary X-ray System
Regulatory Class	: Class II

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Product Code	: MQB
Reference Device:
Trade/Device Name	: DRF 4343 (Pixium RF 4343)
510(k) Number	: K080859
Regulation Number	: 21 CFR 892.1650
Regulation Name	: Image intensified Fluoroscopic X-ray system
Regulatory Class	: Class II
Product Code	: JAA and MQB

2. Device Description

3. Indication for use

1717FCC is indicated for digital imaging solution designed for general radiographic system for human It is intended to replace film or screen based radiographic systems in all general purpose anatomy. diagnostic procedures. Not to be used for mammography.

4. Summary of Design Control Risk management

1717FCC digital X-ray detector is a modification of 1717SCC (K171420). 1717FCC was developed for the purpose of retrofitting the stationary X-ray system with a film detector.

The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted.

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5. Summary of the technological characteristics of the device compared to the predicate device:

1717FCC detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate devices, 1717SCC (K171420).

5.1 Scintillator layer

*scintillator layer. ( * scintillator : a phosphor that produces scintillations)

Scintillator Type	Proposed	Predicate
CsI (Cesium Iodide)	1717FCC	1717SCC 127um and1717SCC 140um

5.2 Power source

		Proposed1717FCC	Predicate1717SCC
Power	Type	Power adapter	Power supply
	Model name	AHM85PS24	RP003A
	Dimension	150 X 64 X 37(cable length: 900 mm)	188 X 92 X 41.5
	Weight	0.4	0.5
	Rating	Input: 100-240 V, 1.0 A, 50/60 HzOutput: 24VDC (Max 3.54A)	Input: 100-240VAC (50/60Hz)Output: 24VDC (Max 1.7A)

5.3 Generator specifications

Model	Manufacture	Specification
			32kW	40kW	50kW
CMP 200	Communications & PowerIndustries	kVp	40-125	40-150	40-150
		mA	10-400	10-500	10-630
EDITOR HFe 501	Rontgenwerk Bochum	kVp	40-150
		mA	10-630
UD150L-40E/40F	Shimadzu	kVp	40-150
		mA	@100 kVp- 500(320)
			@80 kVp- 630(400)
PXR-321B	Poskom Co.,Ltd.	kVp	125/150
		mA	500

5.4 Comparison with the predicate device

Characteristic	Proposed Device (K210985)	Predicate Device (K171420)
----------------	---------------------------	----------------------------

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Manufacturer			Rayence Co.,Ltd.		Rayence Co.,Ltd.
Product Name			1717FCC		1717SCC
Feature		Image: 1717FCC		Image: 1717SCC		Similar
Indicationsfor use		1717FCC is indicated for digitalimaging solution designed forgeneral radiographic system forhuman anatomy. It is intended toreplace film or screen basedradiographic systems in all generalpurpose diagnostic procedures. Notto be used for mammography.			1717SCC_127um and1717SCC_140um, are indicatedfor digital imaging solutiondesigned for general radiographicsystem for human anatomy. It isintended to replace film or screenbased radiographic systems in allgeneral purpose diagnosticprocedures. Not to be used formammography.		Same
Detector Type			Amorphous Silicon (a-Si) TFT + PINtype photodiodeIGZO TFT + PIN type photodiode(option)			Amorphous Silicon (a-Si) TFT	Similar
Scintillator			CsI:Tl	1717FCC	CsI:Tl	1717SCC	Similar
Imaging Area			17 x 17 inches			17 x 17 inches		Similar
Pixel matrix			140 type: 3000 x 3000 (Full resolution)280 type: 1500 x 1500 (2x2 binning)420 type: 1000 x 1000 (3x3 binning)560 type: 750 x 750 (4x4 binning)			140 type : 3072 x 3072		Similar
Pixel pitch			140 μm / 280 μm/ 420 μm/ 560 μm			140 μm		Similar
A/D conversion			14 / 16 bit			14 bit / 16 bit	Same
MTF	a-Si TFT		1.0 lp/mm, Typ. 0.5352.0 lp/mm, Typ. 0.2203.0 lp/mm, Typ. 0.0993.5 lp/mm, Typ. 0.073			1.0 lp/mm, Typ. 0.5802.0 lp/mm, Typ. 0.2833.0 lp/mm, Typ. 0.1583.5 lp/mm, Typ. 0.120		Similar
	IGZO TFT		1.0 lp/mm, Typ. 0.5252.0 lp/mm, Typ. 0.2093.0 lp/mm, Typ. 0.0923.5 lp/mm, Typ. 0.064			-
	DQE (0)	a-Si TFT		Typ. 0.751		0 lp/mm, Typ. 0.740		Similar
		IGZO TFT		Typ. 0.766		-
Preview time			<2 seconds			<2 seconds		Same
Data output			RAW		RAW		Same

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	*The RAW files are convertible intoDICOM 3.0 by console S/W	*The RAW files are convertible intoDICOM 3.0 by console S/W
Dimensions	470 x 470 x 50 mm	460 × 460 × 15.5 mm	Similar
Weight	6.0 kg	4 kg (incl. battery)	Similar

5.5 Comparison with Reference Device

Manufacturer	Rayence Co.,Ltd.		Villa Sistemi Medicali
Product Name	1717FCC		DRF 4343 (Pixium RF 4343)
Feature	Image: 1717FCC		Image: DRF 4343	Similar
510(k) number	K210985		K080859
Indicationsforuse	1717FCC is indicated for digitalimaging solution designed forgeneral radiographic system forhuman anatomy. It is intended toreplace film or screen basedradiographic systems in all generalpurpose diagnostic procedures. Notto be used for mammography.		The DRF 4343 is intended tocapture digital images from aradiographic / fluoroscopic systemthrough a dynamic digital flatpanel, to digitalize, archive andreview images and to provide anetwork connection via DICOMprotocol to various output (e.t.hardcopy, softcopy and archive)devices which uses a device.This device is not intended formammography use.	Similar
Detector Type	Amorphous Silicon (a-Si) TFT + PINtype photodiodeIGZO TFT + PIN type photodiode		Amorphous Silicon (a-Si) TFT	Similar
Scintillator	CsI:Tl		CsI:Tl	Same
Imaging Area	17 x 17 inches		17 x 17 inches	Similar
Frame rate	GigE	6 @ (1x1)25 @ (2x2)45 @ (3x3)60 @ (4x4)	8 f/s (RAD), 15 f/s for fluoroscopy	Better
	Camera link	9 @ (1x1)30 @ (2x2)45 @ (3x3)60 @ (4x4)	12 f/s (RAD), 18 f/s for fluoroscopy(large field)
	5GigE	15 @ (1x1)
		30 @ (2x2)45 @ (3x3)60 @ (4x4)
Imageresolution	Upto 3.5 lp/mm		Upto 3.4 lp/mm	Better

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6. Summary of Performance Testing

1717FCC Digital Flat Panel X-Ray Detector has the same indications for use, the same scintillator material (CsI:Tl ), the same generator specifications and the same risk analysis characteristics compared to 1717SCC, the predicate devices (K171420). The pixel matrix and pixel pitch sizes are different imaging areas but the differences do not raise new concerns for the safety and effectiveness of the subject device.

The clinical and non-clinical test report for the subject device were prepared and submitted to FDA to demonstrate the substantial equivalency of the subject device performance compared to the predicate device.

After comparing a broad review of plain radiographic images taken with 1717FCC and 1717SCC_140μm, images obtained with 1717FCC and 1717SCC were equivalent quality for the same view obtained from a similar patient with the 1717SCC 140μm. In general, both the spatial and soft tissue contrast resolution are slightly superior using the 1717FCC. Specifically, the soft tissues on extremity films were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion.

The non-clinical test report contains the MTF, DQE and NPS performance test comparison between the subject device (1717FCC), and the predicate device (1717SCC), by using the identical test equipment and same analysis method described by IEC 62220-1.

The MTF and DQE testing represent the ability to visualize object details of a certain size and contrast. 1717FCC demonstrated equivalent or better performance in terms of MTF and DQE as well as NPS compared to 1717SCC, the predicate device, at all spatial frequencies.

The frame rate and image resolution for 1717 FCC, the subject device, perform better than the specification of the reference device, DRF 4343 (K080859) which are referenced in K131766.

Based on the non-clinical consideration evaluation, the sponsor can claim the substantial equivaleny between the subject device and the predicate device in terms of diagnostic image quality.

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The manufacturing facility is in conformance with the design control procedure requirements specified in 21 CFR 820.30 and the relevant 21CFR820 standards as the records are available for review. Furthermore, the device conforms with all labeling requirements as per 21 CFR Subchapter J, specifically, 21 CFR 10120.30 and 1020.32.

7. Summary for any testing and reference guidance:

A IEC 6220-1-1 Edition 1.0 2015-03 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
A EMC testing were conducted in accordance with standard IEC 60601-1-2: 2014
A IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
♪ Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005, COR1:2006, COR2:2007, AMD1:2012 (Medical electrical equipment Part 1:General requirements for basic safety and essential performance) and IEC 60601-1-6:2010 (Third edition) +A1:2013
A Non-clinical consideration according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices"
"Guidance for the Contents of Premarket Submission for Software Contained in Medical Device".
Pediatric Information for X-ray Imaging Device Premarket Notifications
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

8. Conclusions:

In accordance with the performance outcomes. 1717FCC demonstrated equivalent or better performance compared to 1717SCC(K171420) and SkyPlate (K171461). Therefore, Rayence claims the substantial equivalency between the subject device and the predicate device in terms of diagnostic image quality about 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.