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

    PET-DOSE

    K Number: K042746 · Decision Nov 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    49

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PET-DOSE
    K Number
    K042746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1360
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Comecer S.R.L.
    Date Received
    October 4, 2004
    Decision Date
    November 22, 2004
    Product Code
    KPT
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    KPT Calibrator, Dose, Radionuclide

    Similar 510(k) Clearances

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

    CRC PC Smart Chamber K1

    FDA 510(k)
    FDA Class 2 ·Radiology

    CRC-77tHR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Veenstra Instruments VDC-506 Dose Calibrator

    FDA 510(k)
    FDA Class 2 ·Radiology

    CRC PC WITH SMART CHAMBER

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336

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