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

    PHO. TRAX MODEL 4000 WHOLE BODY SCAN.

    K Number: K760808 · Decision Nov 5, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    56
    Review Days
    24

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    Basic Information

    Device Name
    PHO. TRAX MODEL 4000 WHOLE BODY SCAN.
    K Number
    K760808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    October 12, 1976
    Decision Date
    November 5, 1976
    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

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