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

    BunkerHill BMD

    K Number: K242295 · Decision Apr 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    8
    Review Days
    249

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    Basic Information

    Device Name
    BunkerHill BMD
    K Number
    K242295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BunkerHill Health
    Date Received
    August 2, 2024
    Decision Date
    April 8, 2025
    Product Code
    KGI
    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
    KGI Densitometer, Bone

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    Other Clearances by BunkerHill Health

    K Number Device Name
    K260166 Bunkerhill Contrast CAC
    K260167 Bunkerhill Contrast AVC
    K250662 Bunkerhill MAC
    K250649 Bunkerhill ECG-EF
    K243779 Bunkerhill Abdominal Aortic Quantification (AAQ)
    K243229 Bunkerhill AVC
    K240369 CAC (gated) Algorithm