BEUDAMED
    Product Code: IWN FDA class 1 21 CFR 892.1940

    Cassette, Measurement, Ardran-Crooks

    Radiology

    An Ardran-Crooks measurement cassette is a specialized radiographic test tool used to measure and evaluate the performance characteristics of fluoroscopic and radiographic imaging systems, supporting quality assurance programs in radiology departments. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWN, regulated under 21 CFR 892.1940, within the Radiology medical specialty. This device is GMP exempt.

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

    Basic Information

    Product Code
    IWN
    Device Class
    FDA class 1
    Regulation Number
    892.1940
    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
    K834607 ELECTRONIC KVP CASSETTE