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

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    K Number: K905827 · Decision Jan 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    9
    Review Days
    28

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    Basic Information

    Device Name
    FULL VIEW OMEGA TABLE
    K Number
    K905827
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Med-Tron Products, Inc.
    Date Received
    December 31, 1990
    Decision Date
    January 28, 1991
    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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