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

    CALYPSO SYSTEM WITH DYNAMIC EDGE GATING

    K Number: K102373 · Decision Sep 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    91
    Applicant Total
    5
    Review Days
    41

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    Basic Information

    Device Name
    CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
    K Number
    K102373
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Calypso Medical Technologies, Inc.
    Date Received
    August 20, 2010
    Decision Date
    September 30, 2010
    Product Code
    LHN
    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
    LHN System, Radiation Therapy, Charged-Particle, Medical

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    Other Clearances by Calypso Medical Technologies, Inc.

    K Number Device Name
    K112841 SURFACE BEACON TRANSPONDERS
    K112768 CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
    K080726 CALYPSO 4D LOCALIZATION SYSTEM
    K060906 CALYPSO 4D LOCALIZATION SYSTEM