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

    CALYPSO 4D LOCALIZATION SYSTEM

    K Number: K080726 · Decision May 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    5
    Review Days
    61

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    Basic Information

    Device Name
    CALYPSO 4D LOCALIZATION SYSTEM
    K Number
    K080726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Calypso Medical Technologies, Inc.
    Date Received
    March 14, 2008
    Decision Date
    May 14, 2008
    Product Code
    IYE
    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
    IYE Accelerator, Linear, 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
    K102373 CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
    K060906 CALYPSO 4D LOCALIZATION SYSTEM