BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Cartesion Prime (PCD-1000A/3) V10.21

    K Number: K251370 · Decision Dec 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    97
    Review Days
    213

    Basic Information

    Device Name
    Cartesion Prime (PCD-1000A/3) V10.21
    K Number
    K251370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Canon Medical Systems Corporation
    Date Received
    May 2, 2025
    Decision Date
    December 1, 2025
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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