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

    DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM

    K Number: K852353 · Decision Aug 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    50
    Applicant Total
    3
    Review Days
    65

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    Basic Information

    Device Name
    DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM
    K Number
    K852353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Thomson-Cgr Medical Corp.
    Date Received
    June 3, 1985
    Decision Date
    August 7, 1985
    Product Code
    IXI
    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
    IXI Block, Beam-Shaping, Radiation Therapy

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