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

    Bunkerhill Contrast AVC

    K Number: K260167 · Decision Mar 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    8
    Review Days
    45

    Basic Information

    Device Name
    Bunkerhill Contrast AVC
    K Number
    K260167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BunkerHill Health
    Date Received
    January 20, 2026
    Decision Date
    March 6, 2026
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JAK), ordered by most recent decision date.

    Respiratory Gating for Scanners (2.1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Aquilion ONE (TSX-308A/TSX-306A) V2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Spectral CT Verida Family

    FDA 510(k)
    FDA Class 2 ·Radiology

    True Definition DL

    FDA 510(k)
    FDA Class 2 ·Radiology

    CT Rembra RT; CT Areta RT; CT Rembra

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOMATOM X.cite; SOMATOM X.ceed

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by BunkerHill Health

    K Number Device Name
    K260166 Bunkerhill Contrast CAC
    K250662 Bunkerhill MAC
    K250649 Bunkerhill ECG-EF
    K243779 Bunkerhill Abdominal Aortic Quantification (AAQ)
    K242295 BunkerHill BMD
    K243229 Bunkerhill AVC
    K240369 CAC (gated) Algorithm