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

    DIGITAL NUCLEAR IMAGING SYSTEM

    K Number: K875198 · Decision Jul 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    2
    Review Days
    197

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    Basic Information

    Device Name
    DIGITAL NUCLEAR IMAGING SYSTEM
    K Number
    K875198
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Medasys, Inc.
    Date Received
    December 17, 1987
    Decision Date
    July 1, 1988
    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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