(29 days)
No
The document describes standard image processing techniques (AutoGrid, image pasting, Metal Artifact Reduction Algorithm) and digital radiography technology. There is no mention of AI, ML, or any learning-based algorithms.
No.
Explanation: The device is an X-ray system intended to generate diagnostic radiographic and tomographic images, which is used for diagnosis, not therapy.
Yes
Explanation: The device is intended to generate digital radiographic and tomographic images for the skull, spinal column, chest, abdomen, extremities, and other body parts, which are used for diagnostic purposes, specifically mentioning "diagnostic images" and detection of "lung nodules".
No
The device description explicitly lists hardware components including an Overhead Tube Suspension, wallstand, Table, X-ray generator, and wireless digital detectors. While it includes software features like image processing and an optional standalone console for image processing, it is fundamentally an X-ray system with physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for generating digital radiographic images of various body parts in patients. This is a diagnostic imaging device used on the patient, not a device used to test samples from the patient in a laboratory setting.
- Device Description: The description details components of an X-ray system (tube, wallstand, table, generator, detectors). This aligns with diagnostic imaging equipment, not IVD equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, or controls, which are typical components and uses of IVD devices.
The device is a diagnostic imaging system that uses X-rays to create images for medical diagnosis. While it is used for diagnostic purposes, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
KPR, MQB, IZF
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital Radiographic (X-ray)
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, Discovery XR656 HD with VolumeRad, did not require clinical studies to support substantial equivalence for the changes identified. The additional detector used to verify and validate the Discovery XR656 HD with VolumeRad was the Varex Imaging Corporation XRpad2 4343 HWC-M Flat Panel Detector cleared under K181526. The fundamental algorithm to create the VolumeRad image set is identical to the algorithm cleared under K132261, so it was determined that bench testing was sufficient to show the equivalence between the use of this feature on the Discovery XR656 HD with VolumeRad and the predicate Discovery XR656 products. The introduction of the Metal Artifact Reduction algorithm for the VolumeRad images was also evaluated, and it was determined that bench testing using anthropomorphic phantoms was sufficient to provide evidence that it can reduce the ripple and ghost metal artifacts for VolumeRad images acquired with the Discovery XR656 HD product. 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 acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Discovery XR656 With VolumeRad (Digital Tomosynthesis) (K132261), Discovery XR656 HD (K172869)
Reference Device(s)
Optima XR240amx with AutoGrid (K173602)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 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.
| 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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3
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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 Economic | |
| Technological Development Zone BEIJING 100176 CHINA | |
| Primary Contact | |
| Person: | Chris Paulik |
| Regulatory Affairs Program Manager | |
| GE Healthcare | |
| 262-548-2010 | |
| Christopher.A.Paulik@ge.com | |
| Secondary Contact | |
| Person: | Diane Uriell |
| Regulatory Affairs Director | |
| GE Healthcare | |
| 262-290-8218 | |
| Diane.Uriell@ge.com | |
| Device Trade | |
| Name: | Discovery XR656 HD with VolumeRad |
| Common/Usual | |
| Name: | Digital Radiographic X-Ray System |
| Classification | |
| Names: | |
| Product Code: | Regulation Name: Stationary X-Ray System |
| Regulation: 21 CFR 892.1680 | |
| Classification: Class II | |
| Product Codes: KPR, MQB, IZF | |
| Predicate Device | |
| #1: | Discovery XR656 With VolumeRad (Digital Tomosynthesis) (K132261) |
| Regulation Name: Stationary X-Ray System | |
| Regulation: 21 CFR 892.1680 | |
| Classification: Class II | |
| Product Codes: KPR, MQB, IZF | |
| Predicate Device | |
| #2: | Discovery XR656 HD (K172869) |
| Regulation Name: Stationary X-Ray System | |
| Regulation: 21 CFR 892.1680 | |
| Classification: Class II | |
| Product 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 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. | |
| Intended Use: | General Purpose Digital Radiographic Imaging System |
| Indications for Use: | 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, 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 chest that aid the radiologist in achieving superior detectability of | |
| lung nodules versus posterior-anterior and left lateral views of the chest, at a | |
| comparable radiation level. | |
| The device is not intended for mammographic applications. | |
| Technology: | The Discovery XR656 HD with VolumeRad employs the same fundamental |
| scientific technology and software as its predicate devices. The intended use and | |
| patient populations are the same between Discovery XR656 HD with VolumeRad | |
| and the predicate devices. The indication for use has been updated to include the | |
| VolumeRad indications cleared under K132261, as well as the AutoGrid indications | |
| cleared under reference device Optima XR240amx with AutoGrid (K173602). The | |
| incorporation of the AutoGrid feature is due to the Optima XR240amx and the | |
| Discovery XR656 HD both incorporating the Helix™ image processing software, | |
| and AutoGrid is embedded within this software. The AutoGrid option is only | |
| available for Digital Cassette exposures (when the detector is not docked in the | |
| table 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 a | |
| physical grid has been used to acquire an image. The Discovery XR656 HD with | |
| VolumeRad 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 and | |
| image pasting technique. | |
| The differences being introduced are: | |
| 1. The incorporation of the VolumeRad feature previously available with the | |
| Discovery 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 in | |
| patients either lying down or standing. Volume RAD involves a series of up to 60 | |
| very low dose projection images during a single sweep of the overhead tube | |
| assembly (OTS) with the detectors physically docked in the table or wallstand | |
| and the tube moving within a limited angular range (up to 40 degrees). The | |
| system automatically adjusts collimation throughout the sweep to maintain | |
| radiation in the imaging area selected during exam setup. After a VolumeRad | |
| acquisition, the system uses a filtered back projection (FBP) technique to | |
| reconstruct slices down to a minimum thickness of 1mm parallel to the receptor. | |
| The VolumeRad OTS sweep and image reconstruction algorithms are identical | |
| between the predicate and proposed products. The difference introduced was in | |
| the image acquisition due to the detector resolution change between the | |
| Discovery XR656 and the Discovery XR656 HD products. Also, the Discovery XR656 | |
| HD with VolumeRad provides an optional Metal Artifact Reduction algorithm to | |
| reduce the ripple and ghost artifacts created when metal is present within the | |
| anatomy where the images are acquired. | |
| The Helix™ Workstation incorporates the PC, Monitor, and software of the | |
| Discovery 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 of | |
| Substantial | |
| Equivalence: | 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 for | |
| basic safety and essential performance; | |
| • IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements | |
| for 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 XRay | |
| Equipment; | |
| • IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements | |
| 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 VolumeRad feature with the updated | |
| resolution detectors introduced with Discovery XR656 HD under K172869. These | |
| risks were reviewed and mitigated with design controls. 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 Discovery XR656 HD with VolumeRad were according to the | |
| following EDA guidance documents. | |
| • "Appropriate Use of Voluntary Consensus Standards in Premarket | |
| Submissions 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 Software | |
| Contained in Medical Devices" issued on May 11, 2005. | |
| • "Content of Premarket Submissions for Management of Cybersecurity in | |
| Medical Devices" issued on October 2, 2014. | |
| • "Radio Frequency Wireless Technology in Medical Devices” issued on | |
| August 14, 2013. | |
| • "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging | |
| Devices" issued on September 1, 2016. | |
| • "Recommended Content and Format of Non-Clinical Bench Performance | |
| Testing 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 changes | |
| identified. The additional detector used to verify and validate the Discovery XR656 | |
| HD with VolumeRad was the Varex Imaging Corporation XRpad2 4343 HWC-M Flat | |
| Panel Detector cleared under K181526. The fundamental algorithm to create the | |
| VolumeRad image set is identical to the algorithm cleared under K132261, so it | |
| was determined that bench testing was sufficient to show the equivalence | |
| between the use of this feature on the Discovery XR656 HD with VolumeRad and | |
| the predicate Discovery XR656 products. The introduction of the Metal Artifact | |
| Reduction algorithm for the VolumeRad images was also evaluated, and it was | |
| determined that bench testing using anthropomorphic phantoms was sufficient to | |
| provide evidence that it can reduce the ripple and ghost metal artifacts for | |
| VolumeRad images acquired with the Discovery XR656 HD product. | |
| 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 acceptable results. | |
| Conclusion: | The changes identified for the Discovery XR656 HD with VolumeRad do not result |
| in any new potential safety risks, it has the same technological characteristics, and | |
| perform as well as the devices currently on the market. | |
| After analyzing design verification and validation testing on the bench it is the | |
| conclusion of GE Healthcare that the Discovery XR656 HD with VolumeRad to be as | |
| safe, as effective, and performance is substantially equivalent to the predicate | |
| devices. |
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GE Healthcare 510(k) Premarket Notification Submission
5
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6
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GE Healthcare 510(k) Premarket Notification Submission
7
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