Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.

Device Description

The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light converter. Columnstructurized CsI:Tl scintillator have high resolution performance due to much less light blurring, and is thus available for a longer period of time. CMOS active pixel detector makes extremely low noise level and highly sensitive performance. Due to seamless one chip CMOS, there is no data missing or artifacts. The high physical and functional performance of 0909FCB gives competitive image quality. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.

The 1212FCA 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 an IGZO TFT sensor. This device needs to be integrated with a radiographic imaging system. It 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 for a radiographic diagnosis and analysis.

The subject detectors are connected to a viewing station by ethernet connection cable. There is no wireless option available.

The 0909 FCB and 1212FCA SSXI detectors should be tested and used with compatible X-ray generators which are not part of the imaging receptor device package.

AI/ML Overview

The provided text describes the acceptance criteria and performance of two digital flat-panel X-ray detectors: 0909FCB and 1212FCA. The study is presented as part of a 510(k) premarket notification to the FDA, demonstrating substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating "equivalent or better performance" compared to predicate devices for specific technical metrics rather than predefined acceptance criteria with numerical thresholds. The "reported device performance" is given in comparison to the predicate devices.

Metric (Acceptance Criteria Implicitly: Equivalent or Better than Predicate)	0909FCB Reported Performance (vs. Predicate 1212FCA K202722)	1212FCA Reported Performance (vs. Reference 1717FCC K210985)
Image Quality (Overall)	Equivalent quality for the same view obtained from a similar patient. Soft tissues on extremity films seen with similar clarity. Little difficulty in evaluating a wide range of anatomic structures.	Claimed substantial equivalency in terms of diagnostic image quality.
MTF (Modulation Transfer Function)	Equivalent or better performance at all spatial frequencies.	Equivalent performance at all spatial frequencies.
DQE (Detective Quantum Efficiency)	Equivalent or better performance at all spatial frequencies.	Better performance at all spatial frequencies.
NPS (Noise Power Spectrum)	Performance test comparison done (implies satisfactory performance relative to predicate).	Performance test comparison done (implies satisfactory performance relative to reference).

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state a numerical sample size for the "test set" in terms of patient images or specific test subjects. For 0909FCB, it mentions "a broad review of plain radiographic images taken with 0909FCB and 1212FCA." For the non-clinical tests (MTF, DQE, NPS), these are typically performed on test phantoms rather than patient data.
Data Provenance: The document does not specify the country of origin of the data. The tests are described as non-clinical (phantom-based) and clinical comparisons. The nature of the clinical comparison "obtained from a similar patient" suggests retrospective or concurrent imaging without specifying a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document mentions "physicians and other health care professionals" for intended use and "a correct conclusion" regarding image evaluation, but it does not specify the number or qualifications of experts used to establish ground truth or evaluate the images for the performance study. It's implied that the clinical comparison was based on expert assessment, but details are absent.

4. Adjudication method for the test set:

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the clinical image comparison or for establishing ground truth. The statement "little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion" suggests an unquantified qualitative assessment.

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 MRMC study was performed or described in the provided text. The devices are digital X-ray detectors, not AI-assisted diagnostic software. The focus is on demonstrating equivalent or better image quality compared to predicate hardware.

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

The performance evaluation primarily involved standalone technical performance metrics (MTF, DQE, NPS) measured on test phantoms, which represents the "algorithm only" or device-only performance characteristics. A clinical comparison of resulting images was also conducted, implicitly without a human-in-the-loop component beyond the initial imaging and subsequent qualitative assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical performance tests (MTF, DQE, NPS), the "ground truth" is established by standardized measurement methodologies described by IEC 62220-1. For the qualitative "clinical comparison," the ground truth seems to be implicitly based on the ability of image quality to support a "correct conclusion" for diagnosis and treatment planning, rather than a formal expert consensus or pathology correlation, and is not explicitly defined.

8. The sample size for the training set:

These are hardware devices (X-ray detectors) and not AI algorithms that require a "training set." Therefore, no training set or sample size for a training set is applicable or mentioned.

9. How the ground truth for the training set was established:

As these are hardware devices and not AI algorithms requiring a training set, this question is not applicable.

Summary

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October 18, 2021

Image /page/0/Picture/1 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 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., Ste 610 HOUSTON TX 77054

Re: K212753

Trade/Device Name: 0909FCB, 1212FCA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, JAA Dated: October 12, 2021 Received: October 12, 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

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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 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) K212753

Device Name 0909FCB, 1212FCA

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 K212753

Date 510k summary prepared: October 6th,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	: 0909FCB, 1212FCA
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	:1212FCA
Common Name	: Digital Flat Panel X-ray Detector
510(k) Number	: K202722
Regulation Number	: 21 CFR 892.1680
Regulation Name	: Stationary X-ray System
Regulatory Class	: Class II
Product Code	: MQB

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Reference Device :

Trade/Device Name	:1717FCC
Common Name	: Digital Flat Panel X-ray Detector
510(k) Number	: K210985
Regulation Number	: 21 CFR 892.1680
Regulation Name	: Stationary X-ray System
Regulatory Class	: Class II
Product Code	: MQB, JAA

2. Device Description

The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.

The subject detectors are connected to a viewing station by ethernet connection cable. There is no wireless option available.

The 0909 FCB and 1212FCA SSXI detectors should be tested and used with compatible X-ray generators which are not part of the imaging receptor device package.

3. Indication for use

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to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.

4. Summary of Design Control Risk management

0909FCB digital X-ray detector is a modification of 1212FCA (K202722). 1212FCA is identical to 1212FCA (K202722). 0909FCB and 1212FCA were developed for the purpose of retrofitting the stationary X-ray system with a film detector. 0909FCB is slightly smaller than 1212FCA (K202722). 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.

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

0909FCB detector described in this 510(k) have the same indications for use and similar technical characteristics as its predicate devices, 1212FCA(K202722).

5.1 Scintillator laver

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

	Proposed	Predicate
CsI (Cesium Iodide)	0909FCB, 1212FCA	1212FCA

5.2. Power source

		Proposed0909FCB	Proposed1212FCA	Predicate1212FCA
Power	Type	Power adapter	Power adapter	Power adapter
	Model name	AHM85PS12	AHM85PS24	AHM85PS24
	Dimension	135 X 62 X 37(cable length: 900 mm)	150 X 64 X 37(cable length: 900 mm)	150 X 64 X 37(cable length: 900 mm)
	Weight	0.36kg	0.5kg	0.5kg
	Rating	Input: 100-240 Vac, 1.0 A,50/60 HzOutput: 12VDC (7.08A)	Input: 100-240 Vac, 1.0 A,50/60 HzOutput: 24VDC (Max3.54A)	Input: 100-240 V, 1.0 A,50/60 HzOutput: 24VDC (3.54A)

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5.3 Generator specifications

(1) Generator specifications (0909FCB)

Equipment	Model	Manufacture	Specification
			Large-focus	Small-focus
X-ray generator	HTC-35B	Poskom Co.,Ltd.	kVp40-110mA25-40KW (Power)3.5	kVp40-110mA0.2-10KW (Power)1.1
X-ray tube	DF-151SBR	Toshiba electron Co.,Ltd.	-

(2) Generator specifications (1212FCA)

Model	Manufacture	Specification
		32kW	40kW	50kW
CMP 200	Communications & PowerIndustries	kVp40-125	40-125	40-150
		mA10-400	10-500	10-630
EDITOR HFe 501	Rontgenwerk Bochum	kVp40-150
		mA10-630
UD150L-40E/40F	Shimadzu	kVp40-150
		mA@100 kVp- 500(320)@80 kVp- 630(400)
PXR-321B	Poskom Co.,Ltd.	kVp125/150
		mA500

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Characteristic	Proposed Device		Predicate Device	Similarity
Manufacturer	Rayence Co.,Ltd.		Rayence Co.,Ltd.
Product Name	0909FCB	1212FCA	1212FCA
Feature	Image: 0909FCB	Image: 1212FCA	Image: 1212FCA
510(k) number	K212753	K212753	K202722
Intended Use	Digital Flat PanelX-Ray Detector isindicated for digitalimaging solutiondesigned for humananatomy includinghead, neck, cervicalspine, arm, leg andperipheral (foot,hand, wrist, fingers,etc.). It is intendedto replace filmbased radiographicdiagnostic systemsand provide a casediagnosis andtreatment planningfor physicians andother health careprofessionals. Notto be used formammography.	Digital Flat PanelX-Ray Detector isindicated for digitalimaging solutiondesigned for humananatomy includinghead, neck, cervicalspine, arm, leg andperipheral (foot,hand, wrist, fingers,etc.). It is intendedto replace filmbased radiographicdiagnostic systemsand provide a casediagnosis andtreatment planningfor physicians andother health careprofessionals. Notto be used formammography.	1212FCA is indicatedfor digital imagingsolution designed forhuman anatomyincluding head, neck,cervical spine, arm, legand peripheral (foot,hand, wrist, fingers,etc.). It is intended toreplace film basedradiographic diagnosticsystems and provide acase diagnosis andtreatment planning forphysicians and otherhealth careprofessionals. Not to beused for mammography.	Same
Detector Type	CMOS PhotodiodeArray	IGZO TFT + PIN typephotodiode	IGZO TFT + PIN typephotodiode	0909FCB and1212FCA hasdifferent detectortype but it issame indirectconversionmethod ofRadiation imagedetection
Scintillator	CsI:Tl	CsI:Tl	CsI:Tl	Same
Imaging Area	9 x 9 inches	12 x 12 inches	12 x 12 inches	-
Total Pixelmatrix	2304×2256 (1x1)1152×1128 (2×2)	1536 X 1536 (1x1)768 X 768 (2x2)	1536 X 1536 (1x1)768 X 768 (2x2)	Similar

5.4 Comparison with Predicate Device

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Pixel pitch	90 μm (1x1)180 μm (2x2)	194 μm (1x1)388 μm (2x2)	194 μm (1x1)388 μm (2x2)	Similar
A/D conversion	16 bits	14 / 16 bit	14 / 16 bit	Similar
Frame rate	Camera link (Base)15 fps (1x1)30 fps (2x2)	GigE	18 (1x1)36 (2x2)	GigE	18 (1x1)36 (2x2)	GigE cable type is same.0909FCB has additional camera link type.
	Camera link (Medium)30 fps (1x1)30 fps (2x2)
	GigE10 fps (1x1)30 fps (2x2)
MTF	1.0 lp/mm, 0.6891.5 lp/mm, 0.5122.0 lp/mm, 0.3942.5 lp/mm, 0.274	0.1 lp/mm, 0.5271 lp/mm, 0.3272 lp/mm, 0.2102.5 lp/mm, 0.136	0.1 lp/mm, 0.5271 lp/mm, 0.3272 lp/mm, 0.2102.5 lp/mm, 0.136	Similar
	DQE (0)	0.581	0.778	0.778	Similar
	Preview time	≤2 seconds	≤2 seconds	≤2 seconds	Same
	Data output	RAW*The RAW files are convertible into DICOM 3.0 by console S/W	RAW*The RAW files are convertible into DICOM 3.0 by console S/W	RAW*The RAW files are convertible into DICOM 3.0 by console S/W	Same
Dimensions	245.0 x 245.0 x 55.0mm	334.0 x 326.0 x 49.9 mm	334.0 x 326.0 x 49.9 mm	Similar
Weight	3.2 kg	3.4 kg	3.4 kg	Similar

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Characteristic	Proposed Device		Reference
Manufacturer	Rayence Co.,Ltd.		Rayence Co.,Ltd.	Similarity
Product Name	0909FCB	1212FCA	1717FCC
Feature	Image: 0909FCB	Image: 1212FCA	Image: 1717FCC
510(k) number	K212753	K212753	K210985
Intended Use	Digital Flat PanelX-Ray Detector isindicated for digitalimaging solutiondesigned for humananatomy includinghead, neck, cervicalspine, arm, leg andperipheral (foot,hand, wrist, fingers,etc.). It is intendedto replace filmbased radiographicdiagnostic systemsand provide a casediagnosis andtreatment planningfor physicians andother health careprofessionals. Notto be used formammography.	Digital Flat PanelX-Ray Detector isindicated for digitalimaging solutiondesigned for humananatomy includinghead, neck, cervicalspine, arm, leg andperipheral (foot,hand, wrist, fingers,etc.). It is intendedto replace filmbased radiographicdiagnostic systemsand provide a casediagnosis andtreatment planningfor physicians andother health careprofessionals. Notto be used formammography.	1717FCC is indicatedfor digital imagingsolution designed forgeneral radiographicsystem for humananatomy.It is intended toreplace film or screenbased radiographicsystems in all generalpurpose diagnosticprocedures. Not to beused for mammography.	Similar1717FCC islarge size ofdetectortherefore it canuse whole humananatomy fordigital imagingsolution. In caseof 0909FCB and1212FCA aresmall size ofdetectortherefore it canuse for humananatomyincluding head,neck, cervicalspine, arm, legand peripheral(foot, hand,wrist, fingers,etc.).
Detector Type	CMOSArray	PhotodiodeIGZO TFT + PIN typephotodiode	a-Si TFT + PIN typephotodiodeIGZO TFT + PIN typephotodiode (option)	0909FCB and1717FCC hasdifferent detectortype but it issame indirectconversion method ofRadiation imagedetection
Scintillator	CsI:Tl	CsI:Tl	CsI:Tl	Same
Imaging Area	9 x 9 inches	12 x 12 inches	17 x 17 inches
Total Pixelmatrix	$2304\times2256$ (1x1)$1152\times1128$ (2x2)	$1536 X 1536$ (1x1)$768 X 768$ (2x2)	$3072 X 3072$ (1x1)$1536 X 1536$ (2x2)	Similar

rayence

5.5 Comparison with Reference Device

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					768 X 768 (4x4)		Similar
Pixel pitch	90 (1x1)180 (2×2)		194 µm (1x1)388 µm (2x2)		140 (1x1)280 (2x2)420 (3x3)560 (4x4)


A/Dconversion	16 bits		14 / 16 bit		14 / 16 bits		Similar
Frame rate	Cameralink(Base)	15 fps(1x1)30 fps(2x2)			Camera link	9 fps (1x1)30 fps (2x2)45 fps (3x3)60 fps (4x4)	-GigE cabletype is same.

						-0909FCB and
	Cameralink(Medium)	30 fps(1x1)30 fps(2x2)	GigE	18 (1x1)36 (2x2)	GigE	6 fps (1x1)25 fps (2x2)45 fps (3x3)60 fps (4x4)	1717FCC haveadditionalcamera linktype and 5GigEtype.
	GigE	10 fps(1x1)30 fps(2x2)			5GigE	15 fps (1x1)30 fps (2x2)45 fps (3x3)60 fps (4x4)
MTF	1.0 lp/mm, 0.689		0.1 lp/mm, 0.527		1.0 lp/mm, 0.535		Similar
	1.5 lp/mm, 0.512		1 lp/mm, 0.327		2.0 lp/mm, 0.220
	2.0 lp/mm, 0.394		2 lp/mm , 0.210		3.0 lp/mm, 0.099
	2.5 lp/mm, 0.274		2.5 lp/mm , 0.136		3.5 lp/mm, 0.073
DQE (0)	0.581		0.778		Typ. 0.751		Similar
Preview time	<2 seconds		<2 seconds		<2 seconds		Same
Data output	RAW		RAW		RAW		Same
	*The RAW files are		*The RAW files are		*The RAW files are
	convertible intoDICOM 3.0 by		convertible intoDICOM 3.0 by		convertible into DICOM3.0 by console S/W
	console S/W		console S/W
Dimensions	245.0 X 245.0 X55.0mm		334.0 x 326.0 x 49.9mm		470 x 470 x 50 mm		Similar
Weight	3.2 kg		3.4 kg		6.0 kg		1717FCC islarge size ofdetector,therefore it isheavy thansubjectdevices

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6. Summary of Performance Testing

<0909FCB>

0909FCB Digital Flat Panel X-Ray Detector has the same indications for use, the same scintillator material (CsI:TI ) and the same risk analysis characteristics compared to 1212FCA, the predicate devices (K202722). 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 0909FCB and 1212FCA, the images obtained with 0909FCB and 1212FCA were equivalent quality for the same view obtained from a similar patient with the 1212FCA.

The soft tissues on extremity films were seen with similar clarity for 0909FCB and 1212FCA. There was little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion.

The non-clinical test report contains the MTF, DOE and NPS performance test comparison between the subject device (0909FCB), and the predicate device (1212FCA), 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. 0909FCB demonstrated equivalent or better performance in terms of MTF and DOE compared to 1212FCA, the predicate device, at all spatial frequencies.

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

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 will conform with all labeling requirements as per 21 CFR Subchapter J.

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<1212FCA>

1212FCA Digital Flat Panel X-Ray Detector, the subject device, is identical to 1212FCA (K202722). 1212FCA has similar indications for use, the same scintillator material (CsI:Tl ), the same generator specifications and the same risk analysis characteristics compared to 1717FCC (K210985), the reference devices. The pixel matrix and pixel pitch sizes are different due to different imaging areas but the differences do not raise new concerns for the safety and effectiveness of the subject device.

The non-clinical test report contains the MTF, DQE and NPS performance test comparison between 1212FCA, the subject device, and 1717FCC (K210985), the predicate device, 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. 1212FCA demonstrated equivalent performance in terms of MTF and better performance in terms of DQE compared to 1717FCC (K210985), the predicate device, at all spatial frequencies.

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

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.

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7. Summary for any testing and reference guidance:

♪ 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)
♪ EMC testing were conducted in accordance with standard IEC 60601-1-2: 2014.
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 efficiency Detectors used in radiographic imaging
Non-clinical consideration according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices"
A "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 A

8. Conclusions:

In accordance with the performance outcomes, 0909FCB, 1212FCA demonstrated equivalent or better performance compared to the predicate and reference devices. 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.