BEUDAMED
    Product Code: IWH FDA class 1 21 CFR 892.5740

    Source, Teletherapy, Radionuclide

    Radiology

    A radionuclide teletherapy source is the radioactive material component of a teletherapy unit that generates the radiation beam used to treat cancers and other conditions from a distance outside the body. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWH, regulated under 21 CFR 892.5740, within the Radiology medical specialty.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    IWH
    Device Class
    FDA class 1
    Regulation Number
    892.5740
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.