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

    ORTHORALIX SD/ORTHORALIX SD CEPH

    K Number: K890351 · Decision Jun 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    41
    Applicant Total
    71
    Review Days
    142

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    Basic Information

    Device Name
    ORTHORALIX SD/ORTHORALIX SD CEPH
    K Number
    K890351
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1740
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Philips Medical Systems North America, Inc.
    Date Received
    January 24, 1989
    Decision Date
    June 15, 1989
    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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