BEUDAMED
    Product Code: IYI FDA class 2 21 CFR 892.5900

    Collimator, Orthovoltage, Therapeutic X-Ray

    Radiology

    An orthovoltage therapeutic X-ray collimator is an accessory device used to shape, limit, and direct the X-ray beam during orthovoltage radiation therapy treatments targeting tumors and other lesions. It is classified as FDA Class 2, reflecting moderate risk and a 510(k) premarket notification requirement before marketing. The product code is IYI, regulated under 21 CFR 892.5900, within the Radiology medical specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    2

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    Basic Information

    Product Code
    IYI
    Device Class
    FDA class 2
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K914821 CRS RADIATION BEAM SCANNER
    K900932 37-702 AND 37-703 PC RAINBOW