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

    ECAT SCINTRON PET

    K Number: K130269 · Decision Apr 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    4
    Review Days
    74

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    Basic Information

    Device Name
    ECAT SCINTRON PET
    K Number
    K130269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miegmbh
    Date Received
    February 4, 2013
    Decision Date
    April 19, 2013
    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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    Other Clearances by Miegmbh

    K Number Device Name
    K201807 ANCORIS
    K101768 MIE SCINTRON GAMMA CAMERA SYSTEMS
    K101013 MODIFICATION TO SCINTRON IV