The Discovery XR656 HD is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen. extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing. or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image.

The Discovery XR656 HD incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.

When the VolumeRAD option is included on the system can generate tomographic images of human anatomy including the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages.

When the VolumeRAD option is used for patients undergoing thoracic imaging, it is indicated for the detection of lung nodules. VolumeRad generates diagnostic images of the radiologist in achieving superior detectability of lung nodules versus posterior and left lateral views of the chest, at a comparable radiation level.

The device is not intended for mammographic applications.

Device Description

The Discovery XR656 HD Radiography X-ray System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic radiographic images which can be sent through a DICOM network for applications including printing, viewing, and storage.
The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices.
The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image.
This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any Helix™ acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.

AI/ML Overview

This document is a 510(k) Premarket Notification submission for the GE Healthcare Discovery XR656 HD with VolumeRad. The submission details the device's technical characteristics, intended use, and a comparison to predicate and reference devices to establish substantial equivalence.

Based on the provided text, the device itself (Discovery XR656 HD with VolumeRad) is an X-ray system, not an AI or algorithm. Therefore, the questions related to AI performance metrics such as reader improvement with AI assistance, standalone algorithm performance, and sample sizes for training/test sets specifically for an AI component are not directly applicable.

However, the document does describe the "Metal Artifact Reduction algorithm for VolumeRad" and mentions its evaluation. This suggests an algorithmic component, though not an AI in the common sense of machine learning for diagnosis. The data provided focuses on demonstrating substantial equivalence to predicate devices for the overall system and its features, including the VolumeRad function with updated detectors and the metal artifact reduction algorithm.

Here's an analysis based on the information available, addressing the relevant points:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing substantial equivalence for the Discovery XR656 HD with VolumeRad to predicate devices, rather than defining specific acceptance criteria for a new AI algorithm and reporting its performance against those. The "performance" discussed is related to the overall system's safety and effectiveness, and the ability of the VolumeRad feature to generate diagnostic images comparable to or better than traditional views for lung nodule detection.

The statement regarding VolumeRad: "VolumeRad generates diagnostic images of the radiologist in achieving superior detectability of lung nodules versus posterior and left lateral views of the chest, at a comparable radiation level." acts as a performance claim for the VolumeRad feature itself, which is part of the device.

Acceptance Criteria (Implied for VolumeRad feature)	Reported Device Performance (for VolumeRad)
Aid radiologist in achieving superior detectability of lung nodules	Generates diagnostic images that aid the radiologist in achieving superior detectability of lung nodules.
Comparable radiation level to posterior-anterior and left lateral views	Achieves this superior detectability at a comparable radiation level to posterior-anterior and left lateral views.
Reduce ripple and ghost metal artifacts (for MAR algorithm)	Bench testing using anthropomorphic phantoms was sufficient to provide evidence that it can reduce the ripple and ghost metal artifacts.

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

Test Set for VolumeRad feature and Metal Artifact Reduction Algorithm: The document states that "bench testing using anthropomorphic phantoms was sufficient" for evaluating the Metal Artifact Reduction algorithm and for showing the equivalence of the VolumeRad feature with updated resolution detectors.
- Sample Size: Not explicitly stated as a number of cases or patients from a clinical study for the test set. It refers to "anthropomorphic phantoms."
- Data Provenance: Not human clinical data. The data originates from "anthropomorphic phantoms" used in bench testing. Given it's a GE Healthcare product, typically such testing occurs internally or at partner facilities. The location of the manufacturer is China.
- Retrospective/Prospective: Not applicable as it's bench testing with phantoms.

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

Since the testing was primarily bench testing with anthropomorphic phantoms, there is no mention of human experts establishing ground truth in the context of reading images from a test set. Evaluation would likely involve technical measurements and visual assessment by product development engineers or possibly consulting radiologists for image quality, but this isn't described as a formal ground truth process for a clinical test set.

4. Adjudication Method for the Test Set:

Not applicable, as the evaluation was primarily bench testing with phantoms.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The submission explicitly states: "The subject of this premarket submission, Discovery XR656 HD with VolumeRad, did not require clinical studies to support substantial equivalence for the changes identified."
Effect Size: Not determined, as no such study was performed.

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

The document implies that the fundamental algorithm to create the VolumeRad image set is identical to the algorithm cleared under K132261. The Metal Artifact Reduction algorithm was evaluated via bench testing. While these are algorithmic components, the overall "device" is an X-ray system. The performance claims for VolumeRad are implicitly related to its ability to present images that aid the radiologist (human-in-the-loop). Bench testing of the algorithms was done, but not as a standalone diagnostic AI performance study in the typical sense for clinical claims.

7. Type of Ground Truth Used:

For the technical evaluation of the VolumeRad feature and the Metal Artifact Reduction algorithm, the "ground truth" was established through bench testing using anthropomorphic phantoms. This means known conditions (e.g., presence/absence of nodules, specific metal artifacts) were simulated in the phantoms to assess the system's output.

8. Sample Size for the Training Set:

The document does not describe the development of a new AI algorithm that would typically involve a "training set." The VolumeRad algorithm is stated to be "identical" to a previously cleared algorithm. The Metal Artifact Reduction algorithm is new, but its development process (including any training data if it were a machine learning algorithm) is not detailed. Therefore, the sample size for a training set is not provided.

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

Not applicable as no specific "training set" for a new AI algorithm is described. For the general development of the overall system and its included algorithms, ground truth would be established through engineering specifications, phantom studies for image quality, and comparison against known physical properties.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

July 24, 2019

Christopher Paulik Regulatory Affairs Program Manager GE Hualun Medical Systems Co., Ltd No. 1 Yong Chang North Road, Beijing Economic Technological Development Zone BEIJING, 100176 CHINA

Re: K191699

Trade/Device Name: Discovery XR656 HD with VolumeRad Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB, IZF Dated: June 21, 2019 Received: June 25, 2019

Dear Mr. Christopher Paulik:

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

{1}------------------------------------------------

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 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191699

Device Name Discovery XR656 HD with VolumeRad

Indications for Use (Describe)

The device is not intended for mammographic applications.

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)
-----------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized font, surrounded by a circular border. There are three decorative swirls or droplets placed around the circle, evenly spaced. The logo is presented in a blue color scheme.

510(k) Summary - K191699

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	June 21, 2019
Submitter:	GE Healthcare, (GE HUALUN MEDICAL SYSTEMS CO. Ltd)No.1 Yong Chang North Road, Beijing EconomicTechnological Development Zone BEIJING 100176 CHINA
Primary ContactPerson:	Chris PaulikRegulatory Affairs Program ManagerGE Healthcare262-548-2010Christopher.A.Paulik@ge.com
Secondary ContactPerson:	Diane UriellRegulatory Affairs DirectorGE Healthcare262-290-8218Diane.Uriell@ge.com
Device TradeName:	Discovery XR656 HD with VolumeRad
Common/UsualName:	Digital Radiographic X-Ray System
ClassificationNames:Product Code:	Regulation Name: Stationary X-Ray SystemRegulation: 21 CFR 892.1680Classification: Class IIProduct Codes: KPR, MQB, IZF
Predicate Device#1:	Discovery XR656 With VolumeRad (Digital Tomosynthesis) (K132261)Regulation Name: Stationary X-Ray SystemRegulation: 21 CFR 892.1680Classification: Class IIProduct Codes: KPR, MQB, IZF
Predicate Device#2:	Discovery XR656 HD (K172869)Regulation Name: Stationary X-Ray SystemRegulation: 21 CFR 892.1680Classification: Class IIProduct Codes: KPR, MQB
Reference Devices:	Optima XR240amx with AutoGrid (K173602)
Regulation Name:	Mobile X-Ray System
Regulation:	21 CFR 892.1720
Classification:	Class II
Product Codes:	IZL MQB
Device Description:	The Discovery XR656 HD Radiography X-ray System is designed as a modularsystem with components that include an Overhead Tube Suspension withtube/collimator, wallstand, Table, X-ray generator, and cleared wireless digitaldetectors. The list of detectors verified and validated for use with the DiscoveryXR656 HD system, including their specifications, are provided in the userdocumentation. The System generates diagnostic radiographic images which canbe sent through a DICOM network for applications including printing, viewing, andstorage.The components may be combined in different configurations to meet specificcustomer needs. In addition, upgrade configurations are available for predicatedevices.The optional image pasting function enables the operator to stitch sequentiallyacquired radiographs into a single image.This 510(k) is to incorporate the VolumeRad advanced application that wascurrently available on the Discovery XR656 product onto the Discovery XR656 HD,as well as introduce a new Metal Artifact Reduction Algorithm, and an optionalstandalone console to take any Helix™ acquired images via DICOM (such as from aDiscovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process theimages independently of the system it was acquired on.
Intended Use:	General Purpose Digital Radiographic Imaging System
Indications for Use:	The Discovery XR656 HD is intended to generate digital radiographic images of theskull, spinal column, chest, abdomen, extremities, and other body parts in patientsof all ages. Applications can be performed with the patient sitting, standing, orlying in the prone or supine position and the system is intended for use in allroutine radiography exams. Optional image pasting function enables the operatorto stitch sequentially acquired radiographs into a single image.The Discovery XR656 HD incorporates AutoGrid, which is an optional imageprocessing software installed as a part of the systems Helix image processingsoftware. AutoGrid can be used in lieu of an anti-scatter grid to improve imagecontrast in general radiographic images by reducing the effects of scatterradiation.When the VolumeRAD option is included on the system, the system can generatetomographic images of human anatomy including the skull, spinal column, chest,abdomen, extremities, and other body parts in patients of all ages.When the VolumeRAD option is used for patients undergoing thoracic imaging, it isindicated for the detection of lung nodules. VolumeRad generates diagnosticimages of the chest that aid the radiologist in achieving superior detectability of
lung nodules versus posterior-anterior and left lateral views of the chest, at acomparable radiation level.
The device is not intended for mammographic applications.
Technology:	The Discovery XR656 HD with VolumeRad employs the same fundamentalscientific technology and software as its predicate devices. The intended use andpatient populations are the same between Discovery XR656 HD with VolumeRadand the predicate devices. The indication for use has been updated to include theVolumeRad indications cleared under K132261, as well as the AutoGrid indicationscleared under reference device Optima XR240amx with AutoGrid (K173602). Theincorporation of the AutoGrid feature is due to the Optima XR240amx and theDiscovery XR656 HD both incorporating the Helix™ image processing software,and AutoGrid is embedded within this software. The AutoGrid option is onlyavailable for Digital Cassette exposures (when the detector is not docked in thetable or wallstand), and when a physical grid is required per the protocol database,but not detected as present. AutoGrid is not intended to be applied when aphysical grid has been used to acquire an image. The Discovery XR656 HD withVolumeRad did not change the system software architecture, operator I/F, Tube,or generator. It does incorporate the same 6-axis Overhead Tube Suspension(OTS) and Overhead Bridge that enables the automatic positioning feature andimage pasting technique.
	The differences being introduced are:
	1. The incorporation of the VolumeRad feature previously available with theDiscovery XR656 (K132261) into the Discovery XR656 HD product
	2. An additional Metal Artifact Reduction algorithm for VolumeRad.
	3. Helix™ Workstation.
	The VolumeRad feature allows digital tomographic images of the human body inpatients either lying down or standing. Volume RAD involves a series of up to 60very low dose projection images during a single sweep of the overhead tubeassembly (OTS) with the detectors physically docked in the table or wallstandand the tube moving within a limited angular range (up to 40 degrees). Thesystem automatically adjusts collimation throughout the sweep to maintainradiation in the imaging area selected during exam setup. After a VolumeRadacquisition, the system uses a filtered back projection (FBP) technique toreconstruct slices down to a minimum thickness of 1mm parallel to the receptor.The VolumeRad OTS sweep and image reconstruction algorithms are identicalbetween the predicate and proposed products. The difference introduced was inthe image acquisition due to the detector resolution change between theDiscovery XR656 and the Discovery XR656 HD products. Also, the Discovery XR656HD with VolumeRad provides an optional Metal Artifact Reduction algorithm toreduce the ripple and ghost artifacts created when metal is present within theanatomy where the images are acquired.
	The Helix™ Workstation incorporates the PC, Monitor, and software of theDiscovery XR656 HD and can be used as a standalone console to take any Helix™acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646
	HD, or Optima XR240amx) and process the images independently of the system it
	was acquired on. The images can then be sent via DICOM to a PACS or other
	image review station.
Determination ofSubstantialEquivalence:	Summary of Non-Clinical Tests:The Discovery XR656 HD and its applications comply with voluntary standards:
	• ES60601-1 Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance;
	• IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirementsfor Basic Safety and Essential Performance – Collateral Standard:Electromagnetic Compatibility - Requirements and Tests;
	• IEC 60601-1-3 Medical Elec. Equipment - P. 1: General Req. for Safety 3.Collateral Standard: General Req. for Radiation Protection in Diagnostic XRayEquipment;
	• IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirementsfor safety - Collateral Standard: Usability;
	• IEC 60601-2-54 Medical electrical equipment - Part 2- 54: Particularrequirements for the basic safety and essential performance of X-rayequipment for radiography and radioscopy;
	• IEC 62366 Medical devices - Application of usability engineering to medicalDevices;
	• PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) set.(Radiology).
	The following quality assurance measures were applied to the development of thesystem:
	1. Risk Analysis
	2. Requirements Reviews
	3. Design Reviews
	4. Testing on unit level (Module verification)
	5. Integration testing (System verification)
	6. Performance testing (Verification)
	7. Safety testing (Verification)
	8. Simulated use testing (Validation)
	New risks were identified for incorporating VolumeRad feature with the updatedresolution detectors introduced with Discovery XR656 HD under K172869. Theserisks were reviewed and mitigated with design controls. The mitigations wereverified and validated as a part of the design verification and validation testing thathas been executed with acceptable results. The testing/documentation weprovided for the Discovery XR656 HD with VolumeRad were according to thefollowing EDA guidance documents.

	• "Appropriate Use of Voluntary Consensus Standards in PremarketSubmissions for Medical Devices" issued on September 14, 2018.
	• "Pediatric Information for X-ray Imaging Device Premarket Notifications"issued on November 18, 2017.
	• "Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices" issued on May 11, 2005.
	• "Content of Premarket Submissions for Management of Cybersecurity inMedical Devices" issued on October 2, 2014.
	• "Radio Frequency Wireless Technology in Medical Devices” issued onAugust 14, 2013.
	• "Guidance for the Submission of 510(k)'s for Solid State X-ray ImagingDevices" issued on September 1, 2016.
	• "Recommended Content and Format of Non-Clinical Bench PerformanceTesting Information in Premarket Submissions" issued on April 26, 2019.
	Summary of Clinical Tests:
	The subject of this premarket submission, Discovery XR656 HD with VolumeRad,did not require clinical studies to support substantial equivalence for the changesidentified. The additional detector used to verify and validate the Discovery XR656HD with VolumeRad was the Varex Imaging Corporation XRpad2 4343 HWC-M FlatPanel Detector cleared under K181526. The fundamental algorithm to create theVolumeRad image set is identical to the algorithm cleared under K132261, so itwas determined that bench testing was sufficient to show the equivalencebetween the use of this feature on the Discovery XR656 HD with VolumeRad andthe predicate Discovery XR656 products. The introduction of the Metal ArtifactReduction algorithm for the VolumeRad images was also evaluated, and it wasdetermined that bench testing using anthropomorphic phantoms was sufficient toprovide evidence that it can reduce the ripple and ghost metal artifacts forVolumeRad images acquired with the Discovery XR656 HD product.Design verification and validation testing was performed to confirm that the safetyand effectiveness of the device has not been affected. The test plans and resultshave been executed with acceptable results.
Conclusion:	The changes identified for the Discovery XR656 HD with VolumeRad do not resultin any new potential safety risks, it has the same technological characteristics, andperform as well as the devices currently on the market.After analyzing design verification and validation testing on the bench it is theconclusion of GE Healthcare that the Discovery XR656 HD with VolumeRad to be assafe, as effective, and performance is substantially equivalent to the predicatedevices.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circle. The circle is surrounded by what appear to be water droplets or stylized flourishes, giving the logo a dynamic and fluid appearance. The color of the logo is a bright, solid blue.

GE Healthcare 510(k) Premarket Notification Submission

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has a white border with wave-like designs, giving it a dynamic and modern appearance. The blue color is consistent throughout the logo, providing a clean and recognizable brand identity.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are several white water droplet shapes surrounding the circle. The logo is simple and recognizable, representing the company's brand identity.

GE Healthcare 510(k) Premarket Notification Submission

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. There are water droplet-like shapes surrounding the circle. The logo is blue.

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.