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

    CRC PC Smart Chamber K1

    K Number: K192199 · Decision Sep 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    14
    Review Days
    30

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    Basic Information

    Device Name
    CRC PC Smart Chamber K1
    K Number
    K192199
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1360
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Capintec, Inc.
    Date Received
    August 13, 2019
    Decision Date
    September 12, 2019
    Product Code
    KPT
    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
    KPT Calibrator, Dose, Radionuclide

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