BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    SYNGO VOLUME PERFUSION-CT BODY

    K Number: K073373 · Decision Dec 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    31
    Review Days
    15

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    Basic Information

    Device Name
    SYNGO VOLUME PERFUSION-CT BODY
    K Number
    K073373
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens AG Medical Solutions
    Date Received
    December 3, 2007
    Decision Date
    December 18, 2007
    Product Code
    JAK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    JAK System, X-Ray, Tomography, Computed

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