BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Navigo Workstation 2.3 (FPRMC00039)

    K Number: K250664 · Decision Aug 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    5
    Review Days
    155

    Basic Information

    Device Name
    Navigo Workstation 2.3 (FPRMC00039)
    K Number
    K250664
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    UC-CARE , Ltd.
    Date Received
    March 5, 2025
    Decision Date
    August 7, 2025
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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