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

    SMARTSPOT PRIMAX

    K Number: K080890 · Decision Apr 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    11
    Review Days
    29

    Basic Information

    Device Name
    SMARTSPOT PRIMAX
    K Number
    K080890
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CMT MEDICAL TECHNOLOGIES, LTD.
    Date Received
    March 31, 2008
    Decision Date
    April 29, 2008
    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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