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 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 wireless digital detectors. 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GE HUALUN MEDICAL SYSTEMS CO. Ltd. Discovery XR656 HD (K172869), a digital radiographic X-ray system. The document focuses on demonstrating substantial equivalence to a predicate device (Optima XR646, K143270) rather than presenting a performance study with detailed acceptance criteria and clinical efficacy results for the entire system.

The core of the submission revolves around the change in detector technology from Ultra Wideband (UWB) to WiFi (802.11) for image transfer, utilizing cleared detectors (PerkinElmer XRpad2 3025 HWC-M Flat Panel Detector, K161942, and PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector, K161966).

Here's an breakdown of the information requested, based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria or specific performance metrics (e.g., sensitivity, specificity, accuracy) for the Discovery XR656 HD as a standalone diagnostic tool. Instead, it relies on demonstrating compliance with recognized standards and successful design verification and validation testing to ensure that the modifications (primarily the change to WiFi-enabled detectors) do not negatively impact the device's safety and effectiveness compared to the predicate.

The "Summary of Non-Clinical Tests" section mentions compliance with several voluntary standards. While these standards implicitly contain performance requirements, the specific numerical acceptance criteria for those requirements and the actual measured performance of the Discovery XR656 HD are not detailed in this summary.

Acceptance Criteria (Inferred from Compliance and EQUIVALENCE claims)	Reported Device Performance (as stated in summary)
Compliance with ES60601-1 (Basic safety and essential performance)	Device and its applications comply with ES60601-1.
Compliance with IEC 60601-1-2 (Electromagnetic Compatibility)	Device and its applications comply with IEC 60601-1-2.
Compliance with IEC 60601-1-3 (Radiation Protection)	Device and its applications comply with IEC 60601-1-3.
Compliance with IEC 60601-1-6 (Usability)	Device and its applications comply with IEC 60601-1-6.
Compliance with IEC 60601-2-54 (X-ray equipment for radiography and radioscopy)	Device and its applications comply with IEC 60601-2-54.
Compliance with IEC 62366 (Application of usability engineering)	Device and its applications comply with IEC 62366.
Compliance with PS 3.1 - 3.20 DICOM set	Device and its applications comply with PS 3.1 - 3.20 DICOM set.
Mitigation of risks identified for wireless image transfer	Risks were reviewed and mitigated with design controls and labeling. Mitigations were verified and validated with acceptable results.
Safety and effectiveness not affected by modifications	Design verification and validation testing performed confirmed that safety and effectiveness have not been affected.
No new potential safety risks	This update to the system does not result in any new potential safety risks.
Same technological characteristics as predicate	Has the same technological characteristics.
Performs as well as predicate devices	Performs as well as the devices currently on the market.
Safe, effective, and substantially equivalent to predicate devices	After analyzing design verification and validation testing, it is concluded that the Discovery XR656 HD is as safe, as effective, and performance is substantially equivalent to the predicate devices.

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

The document states, "The subject of this premarket submission, Discovery XR656 HD, did not require clinical studies to support substantial equivalence for the incorporation WiFi (802.11) enabled detectors due to these detectors having their own 510(k) clearance."

Therefore, for the Discovery XR656 HD itself, there was no specific clinical "test set" and corresponding sample size for demonstrating diagnostic performance beyond its cleared components. The evaluation focused on non-clinical design verification and validation. The "testing/documentation" mentioned was "according to... FDA guidance documents" (for software and cybersecurity), and these were "bench" tests.

The cleared detectors (PerkinElmer XRpad2 3025 HWC-M and 4336 HWC-M) would have had their own clinical data for their respective 510(k) clearances (K161942 and K161966), but that data is not provided here for the Discovery XR656 HD system.

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)

Since no clinical studies were performed for the Discovery XR656 HD's diagnostic performance, there was no test set requiring expert-established ground truth in the context of diagnostic accuracy. The ground truth for the training of the system's image processing (if applicable, which falls under "image processing algorithms to accommodate multiple image matrix sizes") is not detailed here.

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

Not applicable as no clinical test set for diagnostic performance was conducted for this submission.

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

Not applicable. This device is a digital radiographic X-ray system, not an AI-assisted diagnostic tool in the sense of providing automated readings or decision support. The "image processing algorithms" mentioned are for accommodating different image matrix sizes and are not described as AI for diagnostic assistance. There is no mention of an MRMC study or AI assistance.

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

Not applicable. This is a medical imaging system, not a standalone algorithm. The "image processing algorithms" are integrated into the system, and their performance is evaluated as part of the overall system's technical validity, not as a standalone diagnostic algorithm.

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

As no clinical study for diagnostic performance was required or conducted for this 510(k) submission, the concept of "ground truth" (in the diagnostic sense) for this specific submission is not present. The "ground truth" for the system's functionality was established through design verification and validation testing against engineering specifications and industry standards.

8. The sample size for the training set

The document does not specify a training set sample size. While "image processing algorithms" are mentioned, implying potential machine learning components, no details on their training are provided. The focus of the submission is on hardware and communication changes, and the safety and effectiveness of the system with these changes.

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

Not applicable. No information is provided about a training set or its ground truth establishment.

Summary

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GE HUALUN MEDICAL SYSTEMS CO. Ltd. % Kenny Ma Regulatory Affairs Manager No.1 YongChang North Road, Economic Technological Development Zone Beijing, 100176 Beijing CHINA

Re: K172869

Trade/Device Name: Discovery XR656 HD Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MOB Dated: September 14, 2017 Received: September 20, 2017

Dear Kenny Ma:

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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

October 20, 2017

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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.

Robert Oaks

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)

K172869 Device Name Discovery XR656 HD

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)

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510(k) Summary

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

Date:	October 19, 2017
Submitter:	GE Healthcare, (GE HUALUN MEDICAL SYSTEMS CO. Ltd)No.1 Yong Chang North Road, Beijing EconomicTechnological Development Zone BEIJING 100176 CHINA
Primary ContactPerson:	Kenny MaRegulatory Affairs ManagerGE Healthcare, (GE HUALUN MEDICAL SYSTEMS CO. Ltd)Office: +86 18101130591Email: Kenny.Ma@ge.com
Secondary ContactPerson:	Chris PaulikRegulatory Affairs ManagerGE Healthcare, (GE Medical Systems, LLC)+1 262-548-2010Email: Christopher.A.Paulik@ge.com
Device Trade Name:	Discovery XR656 HD
Common/Usual Name:	Digital Radiographic X-Ray System
Classification Names:Product Code:	Regulation Name: Stationary X-Ray SystemRegulation: 21 CFR 892.1680Classification: Class IIProduct Codes: KPR, MQB
Predicate Device:	Optima XR646 (K143270)Regulation Name: Stationary X-Ray SystemRegulation: 21 CFR 892.1680Classification: Class IIProduct Codes: KPR, MQB
Reference Devices:	1) PerkinElmer XRpad2 3025 HWC-M Flat Panel Detector (K161942)Regulation Name: Stationary X-Ray SystemRegulation: 21 CFR 892.1680Classification: Class IIProduct Codes: MQB2) PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector (K161966)Regulation Name: Stationary X-Ray SystemRegulation: 21 CFR 892.1680Classification: Class IIProduct Codes: MQB3) Discovery XR656 With VolumeRad (Digital Tomosynthesis) (K132261)Regulation Name: Stationary X-Ray SystemRegulation: 21 CFR 892.1680Classification: Class IIProduct Codes: KPR, MQB, IZF
Device Description:	The Discovery XR656 HD Radiography X-ray System is designed as amodular system with components that include an Overhead TubeSuspension with tube/collimator, wallstand, Table, X-ray generator,and wireless digital detectors. The System generates diagnosticradiographic images which can be sent through a DICOM networkfor applications including printing, viewing, and storage.The components may be combined in different configurations tomeet specific customer needs. In addition, upgrade configurationsare available for predicate devices.The optional image pasting function enables the operator to stitchsequentially acquired radiographs into a single image.
Intended Use:	General Purpose Digital Radiographic Imaging System
Indications for Use:	The Discovery XR656 HD is intended to generate digital radiographicimages of the skull, spinal column, chest, abdomen, extremities, andother body parts in patients of all ages. Applications can beperformed with the patient sitting, standing, or lying in the prone orsupine position and the system is intended for use in all routineradiography exams. Optional image pasting function enables theoperator to stitch sequentially acquired radiographs into a singleimage.The device is not intended for mammographic applications.
Technology:	The Discovery XR656 HD employs the same fundamental scientifictechnology as its predicate device. The intended use and patientpopulations are the same between Discovery XR656 HD andpredicate device. The indication for use is the same except that
Discovery XR656 HD does not include the Dual Energy advancedapplication that is provided with the predicate device. The DiscoveryXR656 HD did not change system software architecture, operatorI/F, Tube, or generator. It does incorporate the same 6-axisOverhead Tube Suspension (OTS) and Overhead Bridge that enablesthe automatic positioning feature and image pasting techniquefrom the referenced Discovery XR656 (K132261), but does notinclude the VolumeRad indication from this referenced device. Thedifference being introduced with the Discovery XR656 HD is thatexposures can be captured with cleared detectors of multiple sizes.These cleared detectors utilize WiFi (802.11) instead of UltraWideband (UWB) technology to transfer the image to the system. Toaccommodate the cleared wireless detectors, the Discovery XR656HD changed the following from the predicate device:
	Wireless communication hardware for detectorcommunication was changed from UWB to WiFi (802.11) Elevating Table and Wallstand Detector Housing geometryand its associated detector charging hardware andfirmware to accommodate the 17 inch x 14 inch clearedwireless detectors System software to accomplish the following: WiFi (802.11) association and pairing with thecleared wireless detectors Synchronizing the image acquisition and imageretrieval from the cleared wireless detectors Image processing algorithms to accommodatemultiple image matrix sizes User interface updates for image acquisition to incorporatethe cleared wireless detectors into the user workflow
Determination ofSubstantialEquivalence:	Summary of Non-Clinical Tests:
	The Discovery XR656 HD and its applications comply with voluntarystandards:
	ES60601-1 Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance ; IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: GeneralRequirements for Basic Safety and Essential Performance –Collateral Standard: Electromagnetic Compatibility -Requirements and Tests ; IEC 60601-1-3 Medical Elec. Equipment - P. 1: General Req. forSafety 3. Collateral Standard: General Req. for RadiationProtection in Diagnostic XRay Equipment ; IEC 60601-1-6 Medical electrical equipment - Part 1-6: Generalrequirements for safety - Collateral Standard: Usability ;
•	IEC 60601-2-54 Medical electrical equipment - Part 2- 54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy;
•	IEC 62366 Medical devices - Application of usability engineering to medical Devices;
•	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 the system:
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 wireless image transfer between the cleared wireless detector and the base system. These risks were reviewed and mitigated with design controls and labeling. The mitigations were verified and validated as a part of the design verification and validation testing that has been executed with acceptable results. The testing/documentation we provided for the device Discovery XR656 HD were according to the following FDA guidance documents:
•	Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices;
•	Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Summary of Clinical Tests:
The subject of this premarket submission, Discovery XR656 HD, did not require clinical studies to support substantial equivalence for the incorporation WiFi (802.11) enabled detectors due to these detectors having their own 510(k) clearance. The detectors used to verify and validate the Discovery XR656 HD were the PerkinElmer, Inc. XRpad2 3025 HWC-M Flat Panel Detector cleared under K161942 and the PerkinElmer, Inc. XRpad2 4336 HWC-M Flat Panel Detector cleared under K161966.
Design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with
Conclusion:	The Discovery XR656 HD device incorporates cleared radiographicdetectors to capture radiographic images and utilizes a tether orwireless technology to transfer the images to the base system. Thisupdate to this system does not result in any new potential safetyrisks, it has the same technological characteristics, and perform aswell as the devices currently on the market.
	After analyzing design verification and validation testing on thebench it is the conclusion of GE Healthcare that the Discovery XR656HD to be as safe, as effective, and performance is substantiallyequivalent to the predicate devices.

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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.