BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    HeartFocus (V.1.1.1)

    K Number: K242807 · Decision Apr 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    199

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    Basic Information

    Device Name
    HeartFocus (V.1.1.1)
    K Number
    K242807
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deski
    Date Received
    September 17, 2024
    Decision Date
    April 4, 2025
    Product Code
    QJU
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence

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    Other Clearances by Deski

    K Number Device Name
    K260780 HeartFocus