BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    InVision Precision Cardiac Amyloid

    K Number: K243866 · Decision May 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    155

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    Basic Information

    Device Name
    InVision Precision Cardiac Amyloid
    K Number
    K243866
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    InVision Medical Technology Corporation
    Date Received
    December 17, 2024
    Decision Date
    May 21, 2025
    Product Code
    SDJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SDJ Adjunctive Cardiac Amyloidosis Status Indicator

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    Other Clearances by InVision Medical Technology Corporation

    K Number Device Name
    K232331 InVision Precision LVEF (LVEF)