BEUDAMED
    Product Code: IYQ FDA class 1 21 CFR 892.1380

    Phantom, Flood Source, Nuclear

    Radiology

    A nuclear flood source phantom is a device used to test the uniformity and performance of scintillation cameras and other nuclear medicine detectors by providing a uniform distribution of radioactivity across the detector field. It is classified as FDA Class 1, reflecting the lowest level of regulatory control, with only general controls required and no premarket notification necessary. The product code is IYQ, regulated under 21 CFR 892.1380, within the Radiology medical specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    IYQ
    Device Class
    FDA class 1
    Regulation Number
    892.1380
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.