BEUDAMED
    Product Code: JAR FDA class 1 21 CFR 892.1420

    Phantom, Test-Pattern, Radionuclide

    Radiology

    A radionuclide test-pattern phantom is a device containing a known distribution of radioactive material arranged in geometric patterns, used to evaluate and calibrate the spatial resolution, linearity, and uniformity of nuclear medicine imaging equipment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification required. The product code is JAR, regulated under 21 CFR 892.1420, within the Radiology medical specialty. No special flags apply to this device.

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

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    Basic Information

    Product Code
    JAR
    Device Class
    FDA class 1
    Regulation Number
    892.1420
    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.