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

    COLLIMATOR MODEL A280BLE & MODEL A280-BLM

    K Number: K861942 · Decision Jul 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    22
    Applicant Total
    5
    Review Days
    66

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    Basic Information

    Device Name
    COLLIMATOR MODEL A280BLE & MODEL A280-BLM
    K Number
    K861942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    D&R X-Ray Products, Inc.
    Date Received
    May 20, 1986
    Decision Date
    July 25, 1986
    Product Code
    IZW
    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
    IZW Collimator, Automatic, Radiographic

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    Other Clearances by D&R X-Ray Products, Inc.

    K Number Device Name
    K862734 CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND
    K861941 COLLIMATOR MODEL A280BLMD & MODEL A280BLMP
    K861940 RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-T
    K850948 TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER