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

    SATURN 8000

    K Number: K120380 · Decision Mar 9, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    6
    Review Days
    31

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    Basic Information

    Device Name
    SATURN 8000
    K Number
    K120380
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    New Medical Co., Ltd.
    Date Received
    February 7, 2012
    Decision Date
    March 9, 2012
    Product Code
    MQB
    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
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

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    Other Clearances by New Medical Co., Ltd.

    K Number Device Name
    K110210 SATURN 8000-GS
    K080589 SATURN 9000-810
    K072984 SATURN 9000-550
    K072983 SATURN 9000-750
    K063710 SATURN 9000