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

    FOCUS RTP SYSTEM

    K Number: K973936 · Decision Jun 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    124
    Same Product Code
    717
    Applicant Total
    23
    Review Days
    229

    Basic Information

    Device Name
    FOCUS RTP SYSTEM
    K Number
    K973936
    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
    October 15, 1997
    Decision Date
    June 1, 1998
    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 COMPUTERIZED MEDICAL SYSTEMS, INC.

    K Number Device Name
    K110730 MONACO RTP SYSTEM
    K102216 XIO RTP SYSTEM
    K092132 XIO RTP SYSTEM
    K091179 MONACO RTP SYSTEM, VMAT OPTION
    K080799 ATLAS-BASED AUTOSEGMENTATION
    K071938 MONACO RTP SYSTEM
    K032762 XIO RADIATION TREATMENT PLANNING SYSTEM
    K032100 I-BEAM
    K020027 FOCUS RADIATION TREATMENT PLANNING SYSTEM
    K013112 FOCAL SIM
    Search all 23 clearances from COMPUTERIZED MEDICAL SYSTEMS, INC. →