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

    CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC

    K Number: K896609 · Decision Jan 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    71
    Review Days
    175

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    Basic Information

    Device Name
    CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC
    K Number
    K896609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Philips Medical Systems North America, Inc.
    Date Received
    August 9, 1989
    Decision Date
    January 31, 1990
    Product Code
    IZH
    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
    IZH System, X-Ray, Mammographic

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