BEUDAMED
    Product Code: NZT FDA class 2 21 CFR 892.5050

    Dosimeter, Ionizing Radiation, Implanted

    Radiology

    The Dosimeter, Ionizing Radiation, Implanted (product code NZT) is an implantable radiation dosimetry device used to verify the radiation dose delivered to organs during external radiation therapy, enabling clinicians to confirm accurate dose delivery and protect surrounding healthy tissue. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 892.5050 within the Radiology specialty. This device carries an implant flag due to its temporary placement within the body during treatment.

    View on FDA
    510(k)s
    7
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    5
    Years Active
    18

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    Basic Information

    Product Code
    NZT
    Device Class
    FDA class 2
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

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

    Definition

    Verify radiation dose to organs from external radiation therapy.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K250083 PRO-DOSE System
    K182395 OARtrac System
    K162954 OARtrac System with Patient Specific Reusable Universal PSD Sensors
    K150719 OARtrac System with Skin Sensors
    K141154 OARTRAC SYSTEM
    K083035 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
    K080004 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM