BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    PHILIPS DSI SYSTEM RELEASE 3.2

    K Number: K920793 · Decision Jul 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    11
    Applicant Total
    111
    Review Days
    147

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    Basic Information

    Device Name
    PHILIPS DSI SYSTEM RELEASE 3.2
    K Number
    K920793
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1620
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems, Inc.
    Date Received
    February 21, 1992
    Decision Date
    July 17, 1992
    Product Code
    IZJ
    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
    IZJ Camera, X-Ray, Fluorographic, Cine Or Spot

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