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

    PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2

    K Number: K031333 · Decision May 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    198
    Applicant Total
    71
    Review Days
    15

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    Basic Information

    Device Name
    PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
    K Number
    K031333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems North America, Inc.
    Date Received
    April 28, 2003
    Decision Date
    May 13, 2003
    Product Code
    IZI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IZI System, X-Ray, Angiographic

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