BEUDAMED
    Product Code: IZS FDA class 2 21 CFR 892.1610

    Aperture, Radiographic

    Radiology

    A radiographic aperture is a collimating accessory used to define and restrict the X-ray beam to the region of clinical interest, reducing patient dose and improving image contrast by limiting scatter radiation. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is IZS, 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
    —

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    Basic Information

    Product Code
    IZS
    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
    K895084 APERTURE