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

    ATLAS-BASED AUTOSEGMENTATION

    K Number: K080799 · Decision Aug 7, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    91
    Applicant Total
    23
    Review Days
    139

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    Basic Information

    Device Name
    ATLAS-BASED AUTOSEGMENTATION
    K Number
    K080799
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Computerized Medical Systems, Inc.
    Date Received
    March 21, 2008
    Decision Date
    August 7, 2008
    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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