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

    UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE

    K Number: K936136 · Decision Jan 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    10
    Review Days
    34

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    Basic Information

    Device Name
    UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE
    K Number
    K936136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ge Dec Medical Systems
    Date Received
    December 22, 1993
    Decision Date
    January 25, 1994
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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    Other Clearances by Ge Dec Medical Systems

    K Number Device Name
    K000221 SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
    K993687 UROVIEW 2800
    K992506 MINI 6800 DIGITAL MOBILE C-ARM
    K974355 INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
    K970063 SERIES 7600 MOBILE DIGITAL C-ARM
    K963952 SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
    K950781 COMPACT 7600
    K951765 SERIES 6600 DIGITAL MOBILE C-ARM
    K940295 UROVIEW MODEL 2600