Optima XR646 HD

K173612 · Ge Hualun Medical Systems Co. , Ltd. · KPR · Dec 11, 2017 · Radiology

Device Facts

• Record ID: K173612
• Device Name: Optima XR646 HD
• Applicant: Ge Hualun Medical Systems Co. , Ltd.
• Product Code: KPR · Radiology
• Decision Date: Dec 11, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Optima XR646 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 Story

Optima XR646 HD is a stationary digital radiographic X-ray system; generates digital images of human anatomy for general radiography. System utilizes wireless flat panel digital detectors; captures X-ray signals; processes data through an X-ray image chain. Output is a digital image transmitted via DICOM network for viewing, printing, and storage. Operated by clinical staff in a radiology setting. Features an image pasting function to stitch sequentially acquired radiographs into a single image. Device is a lower-cost version of the predicate; utilizes one-axis motorized motion in the Overhead Tube Suspension (OTS) instead of five-axis. Parallel image acquisition method is derived from referenced device. Benefits include efficient diagnostic imaging for routine exams.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including module verification, system integration, performance testing, safety testing, and simulated use validation. Compliance with voluntary standards (IEC 60601 series) and quality assurance measures (risk analysis, design reviews) demonstrated safety and effectiveness.

Technological Characteristics

Stationary digital X-ray system; utilizes wireless flat panel digital detectors. Features one-axis motorized Overhead Tube Suspension (OTS). Connectivity via DICOM network. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, and IEC 62366 standards. Software development follows FDA guidance for medical device software and cybersecurity.

Indications for Use

Indicated for patients of all ages requiring digital radiographic imaging of the skull, spinal column, chest, abdomen, and extremities. Not indicated for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Discovery XR656 HD (K172869)

Reference Devices

• Optima XR646 (K143270)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".

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

### December 11, 2017

### Re: K173612

Trade/Device Name: Optima XR646 HD Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: November 22, 2017 Received: November 22, 2017

Dear Mr. 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 (OS) 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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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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

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)

K173612

Device Name Optima XR646 HD

Indications for Use (Describe)

The Optima XR646 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.

Type of Use (Select one or both, as applicable)

| <span style="font-size:10pt;"> <span style="font-family:Wingdings;">ü</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt;"> <span style="font-family:Wingdings;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular border. The color of the logo is a light blue, and the background is white.

# GE Healthcare 510(k) Premarket Notification Submission

### 510(k) Summary

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

| Date prepared: | November 16, 2017 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare, (GE HUALUN MEDICAL SYSTEMS CO. Ltd)<br>No.1 Yong Chang North Road, Beijing Economic Technological<br>Development Zone BEIJING 100176 CHINA |
| Primary Contact Person: | Kenny Ma<br>Regulatory Affairs Manager<br>GE Healthcare, (GE HUALUN MEDICAL SYSTEMS CO. Ltd)<br>Office: [phone]<br>Email: [e-mail] |
| Secondary Contact<br>Person: | Christopher Paulik<br>Regulatory Affairs Manager<br>GE Healthcare, (GE Medical Systems, LLC)<br>[phone]<br>Email: [e-mail] |
| Device Trade Name: | Optima XR646 HD |
| Common/Usual Name: | Digital Radiographic X-Ray System |
| Classification Names:<br>Product Code: | Regulation Name: Stationary X-Ray System<br>Regulation: 21CFR 892.1680<br>Classification: Class II<br>Product Codes: KPR, MQB |
| Predicate Device: | Discovery XR656 HD (K172869)<br>Regulation Name: Stationary X-Ray System<br>Regulation: 21 CFR 892.1680<br>Classification: Class II<br>Product Codes: KPR, MQB |
| Reference Devices: | Optima XR646 (K143270)<br>Regulation Name: Stationary X-Ray System<br>Regulation: 21 CFR 892.1680<br>Classification: Class II<br>Product Codes: KPR, MQB |
| Device Description: | The Optima XR646 HD is designed to be a lower cost version of the<br>predicate device, the Discovery XR656 HD (K172869). Like the<br>Discovery XR656 HD, the Optima XR646 HD is a radiographic X-ray<br>system capable of generating radiographic images of human<br>anatomy.<br>The Optima XR646 HD is designed to support radiographic<br>applications using previously cleared flat panel wireless digital<br>detectors. The system generates digital images for general<br>radiography by means of its X-Ray image chain. The resulting digital<br>image can be sent through a DICOM network for applications such<br>as printing, viewing and storage. |
| Intended Use: | General Purpose Digital Radiographic Imaging System |
| Indication for Use: | The Optima XR646 HD is intended to generate digital radiographic<br>images of the skull, spinal column, chest, abdomen, extremities, and<br>other body parts in patients of all ages. Applications can be<br>performed with the patient sitting, standing, or lying in the prone or<br>supine position and the system is intended for use in all routine<br>radiography exams. Optional image pasting function enables the<br>operator to stitch sequentially acquired radiographs into a single<br>image.<br>The device is not intended for mammographic applications. |
| Technology: | The Optima XR646 HD employs the same fundamental scientific<br>technology as its predicate device. The intended use and indications for<br>use are the same between Optima XR646 HD and predicate device. A<br>majority of the Optima XR64 HD hardware is identical to that of the<br>predicate Discovery XR656 HD system. The primary difference is a<br>change from five axis motorized motion to one axis motorized motion in<br>the Overhead Tube Suspension (OTS). The removal of these axes of<br>motion requires the systems image pasting feature to acquire images<br>in a parallel sequence identical to the referenced Optima XR646<br>(K143270) instead of rotating the x-ray tube like the predicate. |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests: |
| | The Optima XR646 HD and its applications comply with voluntary<br>standards: |
| | • ES60601-1 Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance ; |
| | • IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General<br>Requirements for Basic Safety and Essential Performance -<br>Collateral Standard: Electromagnetic Compatibility -<br>Requirements and Tests ; |
| | • IEC 60601-1-3 Medical Elec. Equipment - P. 1: General Req. for<br>Safety 3. Collateral Standard: General Req. for Radiation<br>Protection in Diagnostic XRay Equipment ; |
| | • IEC 60601-1-6 Medical electrical equipment - Part 1-6: General<br>requirements for safety - Collateral Standard: Usability ; |
| | • IEC 60601-2-54 Medical electrical equipment - Part 2- 54:<br>Particular requirements for the basic safety and essential<br>performance of X-ray equipment for radiography and<br>radioscopy ; |
| | • IEC 62366 Medical devices - Application of usability engineering<br>to medical Devices ; |
| | • PS 3.1 - 3.20 Digital Imaging and Communications in Medicine<br>(DICOM) set. (Radiology). |
| | The following quality assurance measures were applied to the<br>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 the modified OTS into the<br>product. These risks were reviewed and mitigated with design<br>controls and labeling. The mitigations were verified and validated as<br>a part of the design verification and validation testing that has been<br>executed with acceptable results. |
| | The testing/documentation we provided for the Optima XR646 HD<br>were according to the following FDA guidance documents: |
| | • Guidance for the Content of Premarket Submissions for Software<br>Contained in Medical Devices. |
| | Content of Premarket Submissions for Management of<br>Cybersecurity in Medical Devices<br>Summary of Clinical Tests:<br>The subject of this premarket submission, Optima XR646 HD, does<br>not require clinical studies to support substantial equivalence for theutilizing parallel image acquisition is currently incorporated in the<br>Optima XR646 x-ray system cleared under K143270. |
| | Design verification and validation testing was performed to confirm<br>that the safety and effectiveness of the device has not been affected.<br>The test plans and results were executed with acceptable results. |
| Conclusion: | The Optima XR646 HD device incorporates a simplified OTS used to<br>position the x-ray source within the x-ray system. The changes in<br>the Optima XR646 HD do not result in any new potential safety risks,<br>the product has the same technological characteristics, and<br>performs as well as other devices currently on the market.<br>After analyzing design verification and validation testing on the<br>bench it is the conclusion of GE Healthcare that the Optima XR646<br>HD is safe and effective, and its performance is substantially<br>equivalent to the predicate devices. |

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# GE Healthcare 510(k) Premarket Notification Submission

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## GE Healthcare 510(k) Premarket Notification Submission

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Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the background is white.

510(k) Premarket Notification Submission