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

    ORALIX PANORAMIC D.C.

    K Number: K852768 · Decision Sep 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    41
    Applicant Total
    111
    Review Days
    83

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    Basic Information

    Device Name
    ORALIX PANORAMIC D.C.
    K Number
    K852768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1740
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Philips Medical Systems, Inc.
    Date Received
    June 28, 1985
    Decision Date
    September 19, 1985
    Product Code
    IZF
    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
    IZF System, X-Ray, Tomographic

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