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

    VIEWSTATION

    K Number: K011694 · Decision Aug 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    13
    Review Days
    90

    Basic Information

    Device Name
    VIEWSTATION
    K Number
    K011694
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    IMPAC MEDICAL SYSTEMS, INC.
    Date Received
    May 31, 2001
    Decision Date
    August 29, 2001
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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    Other Clearances by IMPAC MEDICAL SYSTEMS, INC.

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    K043412 MODIFICATION TO: VIEWSTATION
    K013531 QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00
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