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

    UROVIEW 2800

    K Number: K993687 · Decision Dec 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    10
    Review Days
    50

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    Basic Information

    Device Name
    UROVIEW 2800
    K Number
    K993687
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Dec Medical Systems
    Date Received
    November 1, 1999
    Decision Date
    December 21, 1999
    Product Code
    OWB
    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
    OWB Interventional Fluoroscopic X-Ray System

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    Other Clearances by Ge Dec Medical Systems

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    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
    K936136 UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE