1717WCC and 1717WGC Digital Flat Panel X-Ray Detectors are 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

1717WCC / 1717WGC is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN(IEEE 802.11a/g/n/ac) communication signals images captured to the system and improves the user operability through high-speed processing. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si 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 a separate console SW program (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a diagnostic analysis.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically digital flat panel X-ray detectors (1717WCC / 1717WGC). The document aims to demonstrate substantial equivalence to a predicate device (1717SCN / 1717SGN).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a numeric fashion for clinical performance. Instead, it relies on demonstrating substantial equivalence to a predicate device through a combination of non-clinical (engineering/technical) performance data and clinical considerations (expert review).

The primary non-clinical performance metrics presented are:

Modulation Transfer Function (MTF): Represents the ability to visualize object details of a certain size and contrast. Higher MTF values indicate better resolution.
Detective Quantum Efficiency (DQE): Represents the efficiency of an imaging system in converting X-ray energy into a diagnostically useful image. Higher DQE values indicate better image quality, especially at low doses.

Table of Reported Device Performance (MTF and DQE):

The document presents tables comparing the proposed device (1717WCC / 1717WGC) with the predicate device (1717SCN / 1717SGN) for MTF at various spatial frequencies and DQE(0).

Spatial Frequency	1717WCC_127 (Proposed)	1717SCN (Predicate)	1717WGC_127 (Proposed)	1717SGN (Predicate)
MTF Value (127 µm)
1.0 lp/mm	0.539	0.566	0.557	0.574
2.0 lp/mm	0.262	0.251	0.247	0.269
3.0 lp/mm	0.147	0.123	0.106	0.123
3.5 lp/mm	0.105	0.086	0.067	0.082
3.93 lp/mm	0.086	0.080	0.046	0.076

Spatial Frequency	1717WCC_139 (Proposed)	1717SCN (Predicate)	1717WGC_139 (Proposed)	1717SGN (Predicate)
MTF Value (139 µm)
1.0 lp/mm	0.537	0.566	0.556	0.574
2.0 lp/mm	0.269	0.251	0.260	0.269
3.0 lp/mm	0.145	0.123	0.123	0.123
3.5 lp/mm	0.110	0.086	0.084	0.082
3.59 lp/mm	0.104	0.080	0.078	0.076

Spatial Frequency	1717WCC_140 (Proposed)	1717SCN (Predicate)	1717WGC_140 (Proposed)	1717SGN (Predicate)
MTF Value (140 µm)
1.0 lp/mm	0.580	0.566	0.556	0.574
2.0 lp/mm	0.269	0.251	0.260	0.269
3.0 lp/mm	0.139	0.123	0.123	0.123
3.5 lp/mm	0.098	0.086	0.084	0.082
3.57 lp/mm	0.093	0.081	0.078	0.076

Metric	1717WCC_127 (Proposed)	1717SCN (Predicate)	1717WGC_127 (Proposed)	1717SGN (Predicate)
DQE(0)	0.71	0.700	0.444	0.420

Metric	1717WCC_139 (Proposed)	1717SCN (Predicate)	1717WGC_139 (Proposed)	1717SGN (Predicate)
DQE(0)	0.705	0.700	0.446	0.420

Metric	1717WCC_140 (Proposed)	1717SCN (Predicate)	1717WGC_140 (Proposed)	1717SGN (Predicate)
DQE(0)	0.775	0.700	0.440	0.420

The text concludes: "1717WCC has higher MTF and DQE performance at high spatial frequencies, especially from 2 lp/mm. The comparison of the MTF and DQE for 1717WGC detector demonstrated that the performed almost same with 1717SGN."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "clinical images are taken from both subject devices and reviewed by a licensed US radiologist to render an expert opinion." It also mentions "taking sample radiographs of similar age groups and anatomical structures".

Sample Size: The exact sample size for the clinical test set is not specified in the provided text. It only states "sample radiographs".
Data Provenance: The images were reviewed by a "licensed US radiologist," suggesting the review occurred in the US. However, it does not state the country of origin of the patients or images.
Retrospective or Prospective: The text implies a prospective collection for the comparison ("taking sample radiographs"), but it's not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: "reviewed by a licensed US radiologist." This indicates one expert.
Qualifications: "a licensed US radiologist." No further details on experience (e.g., years, specialization beyond "radiologist") are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Since only one radiologist reviewed the images, there was no adjudication method employed as it's a single-reader 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

MRMC Study: No, an MRMC study was not conducted based on the provided text. The study involved a single radiologist performing a qualitative comparison between images from the new device and the predicate.
Effect Size (AI Assistance): This device is a digital X-ray detector, not an AI algorithm designed to improve human reading. Therefore, this question is not applicable to the context of the provided document. The study's focus was on demonstrating equivalent or superior image quality for the detector itself.

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

This refers to the performance of an AI algorithm. The device here is a hardware component (X-ray detector). While non-clinical 'standalone' performance for the detector was assessed (MTF, DQE measurements), this is not an "algorithm only" performance evaluation in the context of AI. The "clinical consideration" involved a human reading the images.

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

The "ground truth" for the clinical consideration was the expert opinion/qualitative review by a single licensed US radiologist. The assessment was based on visual comparison of image quality, specifically spatial and soft tissue contrast resolution, and the ability to evaluate anatomical structures for a correct conclusion. It was a comparative rather than an absolute "truth" established by a gold standard like pathology.

8. The sample size for the training set

This document describes a 510(k) submission for an X-ray detector, which is a hardware device. It is not an AI/machine learning product that typically requires a "training set" in the conventional sense. Therefore, the concept of a "training set" sample size is not applicable here. The device's performance is based on its physical and electronic characteristics.

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

As explained in point 8, the concept of a "training set" and "ground truth for the training set" is not applicable to this type of device according to the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, connected by a flowing ribbon-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 6, 2016

Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K162519

Trade/Device Name: 1717WCC / 1717WGC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 1, 2016 Received: September 9, 2016

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oals

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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Indications for Use

510(k) Number (if known)

K162519

Device Name

1717WCC 1717WGC

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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1. 510(k) Summary

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: October 3, 2016

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)
(U.S. Designated agent)
Address:	8310 Buffalo Speedway, Houston, TX 77025
Telephone:	+713-467-2607
Fax:	+713-583-8988

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:	1717WCC / 1717WGC
Common Name:	Digital Flat Panel X-ray Detector
Classification Name :	21CFR892.1680 / Stationary x-ray system
Product Code:	90 MQB

Predicate Device :

Manufacturer :	Rayence Co., Ltd.
Device :	1717SCN / 1717SGN
510(k) Number :	K150150
Classification Name :	21CFR892.1680 / Stationary x-ray system
Product Code:	MQB

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2. Device Description

3. Indication for use

4. Summarv of Design Control Risk management

The 1717WCC / 1717WGC digital X-ray detector is a modification of 1717SCN / 1717SGN (K150150). It was developed for the purpose of portable imaging. 1717WCC / 1717WGC is slightly thinner and lighter than 1717SCN / 1717SGN.

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:

1717WCC and 1717WGC detector described in this 510(k) have the same indications for use and similar technical characteristics as the predicate devices, 1717SGN and 1717SCN.

Comparison table 5.1

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Characteristic	ProposedRayence Co.,Ltd.1717WCC / 1717WGC	PredicateRayence Co.,Ltd.1717SCN / 1717SGN
Feature	Image: Proposed Rayence Co.,Ltd. 1717WCC / 1717WGC	Image: Predicate Rayence Co.,Ltd. 1717SCN / 1717SGN
510(k) number	-	K150150
Intended Use	1717WCC and 1717WGC Digital FlatPanel X-Ray Detector are indicated fordigital imaging solution designed forgeneral radiographic system for humananatomy. It is intended to replace film orscreen based radiographic systems in allgeneral purpose diagnostic procedures.Not to be used for mammography.	1717SGN and 1717SCN Digital FlatPanel X-Ray Detector is indicated fordigital imaging solution designed forgeneral radiographic system for humananatomy. It is intended to replace film orscreen based radiographic systems in allgeneral purpose diagnostic procedures.Not to be used for mammography.
Detector Type	Amorphous Silicon, TFT	Amorphous Silicon, TFT
Scintillator	1717WCC1717WGC	CSI:T1Gd2O2S:Tb
	CSI:T1Gd2O2S:Tb	1717SCN1717SGN
Imaging Area	17 x 17 inches	17 x 17 inches
Pixel matrix	127 : 3328 X 3328139, 140 : 3072 X 3072	3072 x 3072
Pixel pitch	127, 139, 140 μm	127 μm
Resolution	3.9 lp/mm	3.9 lp/mm
A/D conversion	14 / 16 bit	14 / 16 bit
Preview time	≤2	<2
Data output	RAW*The RAW files are convertible intoDICOM 3.0 by console S/W	RAW*The RAW files are convertible intoDICOM 3.0 by console S/W
Dimensions	460 × 460 × 15 mm	460 x 460 × 15.5 mm
Weight	3.5 kg (incl. battery)	4 kg
Application	General Radiology system orWireless/Wired portable systemAvailable with upright stand, table,universal stand.	General Radiology system orPortable systemAvailable with upright stand, table,universal stand.
AddedOptionalComponents	Battery & Battery ChargerInterface BoxIrDA module	-
	Proposed	Predicate
CsI(Cesium Iodide)	1717WCC	1717SCN
Gd2O2S:Tb(Gadolinium Oxysulfide)	1717WGC	1717SGN

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5.2 Scintillator layer

1717WCC / 1717WGChas the same Hardware, Software and components. The type of a scintillator layer is different. ( * scintillator : a phosphor that produces scintillations) as described below.

5.3 Added Optional Components (Comparison with Predicate device)

Components	Description
Battery & Battery ChargerImage: Battery and charger	Sources of electricity.
Mobile Battery ChargerImage: Mobile battery charger
Interface BoxImage: Interface box	1) Connector to synchronize the detector and its generator.2) Data transfer and battery charge while the detector is in use(Connect between the detector and Interface Box), Up to threedetectors can be connected.3) Transmitting an image/command between the detector and PC.4) Wireless AP.
IrDA moduleImage: IrDA module	Sharing function for PC and the detector.

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5.4 Recommended Generator Specification

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

Image /page/7/Picture/3 description: The image is a warning sign with a yellow triangle and a black border. Inside the triangle is a black exclamation point. Below the triangle, the word "CAUTION" is written in black, bold letters. The sign is enclosed in a dotted black border.

To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have questions regarding the compatibility issue for other generators which are not listed above, please contact your Rayence representative. ..............................................................................................................................................................................

6. Summary of Performance Testing

1717WCC and 1717WGC Digital Flat Panel X-Ray Detector have the same indications for use, material, form factor, performance, and safety characteristics compared to the predicate devices, 1717SCN and 1717SGN, respectively.

The non-clinical test and clinical consideration test for each subject device were performed to demonstrate the substantial equivalency of the subject devices compared to each respective predicate device. The nonclinical test report contains the MTF, DQE and NPS test results of 1717WCC and 1717WGC by using the identical test equipment and same analysis method described by IEC 62220-1.

The comparative result of the MTF and DQE test for 1717WCC detector with respect to each respective predicate demonstrated that the MTF and DQE of the both subject devices performed better

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510(k) Submission – 1717WCC / 1717WGC

compared with each respective predicate device. The MTF and DQE represents the ability to visualize object details of a certain size and contrast. 1717WCC has higher MTF and DQE performance at high spartial frequencies, especially from 2 1p/mm. The comparison of the MTF and DQE for 1717WGC detector demonstrated that the performed almost same with 1717SGN.

SpatialFrequency	MTF Value
	1717WCC_127	1717SCN	1717WGC_127	1717SGN
1.0 lp/mm	0.539	0.566	0.557	0.574
2.0 lp/mm	0.262	0.251	0.247	0.269
3.0 lp/mm	0.147	0.123	0.106	0.123
3.5 lp/mm	0.105	0.086	0.067	0.082
3.93 lp/mm	0.086	0.080	0.046	0.076

SpatialFrequency	MTF Value
1.0 lp/mm	0.537	0.566	0.556	0.574
2.0 lp/mm	0.269	0.251	0.260	0.269
3.0 lp/mm	0.145	0.123	0.123	0.123
3.5 lp/mm	0.110	0.086	0.084	0.082
3.59 lp/mm	0.104	0.080	0.078	0.076
	1717WCC_139	1717SCN	1717WGC_139	1717SGN

SpatialFrequency	MTF Value
1.0 lp/mm	1717WCC_140	1717SCN	1717WGC_140	1717SGN
1.0 lp/mm	0.580	0.566	0.556	0.574
2.0 lp/mm	0.269	0.251	0.260	0.269
3.0 lp/mm	0.139	0.123	0.123	0.123
3.5 lp/mm	0.098	0.086	0.084	0.082
3.57 lp/mm	0.093	0.081	0.078	0.076

	1717WCC_127	1717SCN	1717WGC_127	1717SGN
DQE(0)	0.71	0.700	0.444	0.420
	1717WCC_139	1717SCN	1717WGC_139	1717SGN
DQE(0)	0.705	0.700	0.446	0.420

	1717WCC_140	1717SCN	1717WGC_140	1717SGN
DQE(0)	0.775	0.700	0.440	0.420

This information will be included as a part of proposed labeling documentation for the end user.

To further demonstrate the substantial equivalency of two devices, clinical images are taken from both subject devices and reviewed by a licensed US radiologist to render an expert opinion. Both the test subject (1717WCC and 1717WGC) and the predicate devices (1717WGC and 1717SGN) have been evaluated and

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compared by taking sample radiographs of similar age groups and anatomical structures in accordance with the test protocol of diagnostic radiography evaluation procedure.

After a broad review of plain radiographic images taken with the 1717WCC and the 1717WGC, the images obtained with the 1717WCC and 1717WGC are superior to the same view obtained from a similar patient with the predicate devices, 1717WGC and 1717SGN. In general, both the spatial and soft tissue contrast resolution are superior using the 1717WGC. 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.

Based on the non-clinical and clinical consideration test and the outcome of a comparative review by an expert for both devices, the sponsor can claim the substantial equivalency between the subject devices and their predicate devices in terms of diagnostic image quality.

The manufacturing facility is in conformance with the design control procedure requirements and the relevant EPRC standards as specified in 21 CFR 802.30 and the records are available for review.

7. Summary for anv testing in the submission:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (Medical electrical equipment Part 1: General requirements for basic safety and essential performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2: 2007.

Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed.

All test results were satisfactory.

	Added function	Risk factor	Discussion
1	Essentialperformance(Image size)	-. Pixel Pitch127/139/140	Pixel Pitch of 127 and 139 are added to the existing 140 type.Therefore, the total pixel matrix, total pixel area, effective and pixel matrix have been changed. The SSXI Nonclinical/Clinical test of the new detector determined that the image quality of the new detector to be substantially equivalent to the predicate device.The revised RM table; Att 3-1 and Att 302 include the following risk: Operational hazard (Incorrect image data) hazard ID (HI-601-1-4.3) which is highlighted in yellow.

8. Summary for risk management activities in the submission:

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2	Wireless	-. Battery	The risk related to a wireless product that uses a battery hasbeen identified and mitigated according to IEC 60601-1,IEC62366 test, and SW validation.
			The revised RM table; Att3-1 and Att 3-2 include thefollowing risk: Operation hazard (Use error)-Incorrectreplacement, Hazard ID (HI-601-1-7.3.3) and Operationhazard-Batter connection, Hazard ID (HI-601-1-15.4.3.2)Att3-3 SW validation also includes HZ 0017-power instabilitycaused by low battery power which is highlighted in yellow.
		-. Wirelesssignal	SW validation also identified the following risk and risk
			management activities regarding the wireless signal; (HZ0017-power instability caused by low battery power.
			(HZ 0019)-Misdiagnosis
			Not possible to check the data validity of all data packets,including CRC value, based on the IrDA communicationtransmission in the PC and the detector/HZ 0020)-MisdiagnosisImage not transmitted to the User PC due to the networktransmission failure.
			Check the connection between the detector and the User-PC

9. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, it is the sponsor's opinion that 1717WCC and 1717WGC is substantially equivalent in comparison with 1717SCN and 1717SGN, the predicate device as described herein.

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.