BEUDAMED
    Product Code: IZT FDA class 2 21 CFR 892.1610

    Cone, Radiographic

    Radiology

    A radiographic cone is a beam-limiting device attached to an X-ray tube housing that shapes and restricts the X-ray beam to a defined area, helping to reduce scatter radiation and patient exposure. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is IZT, regulated under 21 CFR 892.1610, within the Radiology medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    IZT
    Device Class
    FDA class 2
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K924759 COLLIMATOR LIGHT SOURCE