BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3

    K Number: K202679 · Decision Apr 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    2
    Review Days
    209

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    Basic Information

    Device Name
    Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3
    K Number
    K202679
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mcgovern Medical School
    Date Received
    September 15, 2020
    Decision Date
    April 12, 2021
    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 Mcgovern Medical School

    K Number Device Name
    K231731 Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4