BEUDAMED
    Product Code: QVD FDA class 2 21 CFR 892.2055

    Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

    Radiology

    The Radiological Machine Learning Based Quantitative Imaging Software with Change Control Plan is a software-only medical device that employs machine learning algorithms on radiological images to generate quantitative imaging outputs, including view selection, segmentation, and landmarking functions, and is designed with a predetermined change control plan that permits specified modifications to the device's machine learning algorithms over time without requiring a new premarket submission for each update. Classified as FDA Class 2 under regulation 892.2055, it requires 510(k) clearance in the Radiology specialty. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    QVD
    Device Class
    FDA class 2
    Regulation Number
    892.2055
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A radiological machine learning quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The device includes functions to support outputs such as view selection, segmentation and landmarking. The design specifications include planned modifications that may be made to the device consistent with an established predetermined change control plan.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN220063 Caption Interpretation Automated Ejection Fraction Software

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.