BEUDAMED
    Product Code: KQA FDA class 2 21 CFR 892.5900

    Device, Beam Limiting, X-Ray, Therapeutic

    Radiology

    This device is a therapeutic x-ray beam limiting device, such as a collimator used in radiation therapy equipment, designed to precisely shape and restrict the treatment beam to the intended target volume while sparing surrounding healthy tissue. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KQA, regulated under 21 CFR 892.5900 within the Radiology specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    4
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    4
    Years Active
    13

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    Basic Information

    Product Code
    KQA
    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 4 510(k) clearances via K numbers.

    K Number Device Name
    K914784 PAPILLION PROCTOSCOPE
    K885126 PHILIPS RT250 COLLIMATOR (PK8050)
    K844180 THE MCP-70-SE SYSTEM
    K790168 COLLIMATOR, BILATERIAL