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

    HeartFocus

    K Number: K260780 · Decision Jun 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    85

    Basic Information

    Device Name
    HeartFocus
    K Number
    K260780
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deski
    Date Received
    March 10, 2026
    Decision Date
    June 3, 2026
    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
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