BEUDAMED
    Product Code: IWO FDA class 1 21 CFR 892.6500

    Apron, Protective

    Radiology

    A radiological protective apron is a lead-lined or equivalent garment worn by medical personnel and patients to attenuate ionizing radiation and reduce exposure to scatter radiation during radiological procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWO, regulated under 21 CFR 892.6500, within the Radiology medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    IWO
    Device Class
    FDA class 1
    Regulation Number
    892.6500
    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
    K770407 SHIELD, DENTAL X-RAY, PROTECTIVE

    FEI Numbers

    This FDA classification entry is associated with 80 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 80 registration numbers. Click on an entry to view related FDA registrations.