BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇵🇹 Portugal

    PRO-DOSE System

    K Number: K250083 · Decision Oct 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    261

    Basic Information

    Device Name
    PRO-DOSE System
    K Number
    K250083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nu-Rise, SA
    Date Received
    January 13, 2025
    Decision Date
    October 1, 2025
    Product Code
    NZT
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NZT Dosimeter, Ionizing Radiation, Implanted

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