BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SPECTRUM 150 DT

    K Number: K851644 · Decision May 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    2
    Review Days
    32

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    Basic Information

    Device Name
    SPECTRUM 150 DT
    K Number
    K851644
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Raytheon Medical Systems
    Date Received
    April 19, 1985
    Decision Date
    May 21, 1985
    Product Code
    IYX
    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
    IYX Camera, Scintillation (Gamma)

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