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

    ZIEHM VISION RFD

    K Number: K083545 · Decision May 15, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    7
    Review Days
    168

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    Basic Information

    Device Name
    ZIEHM VISION RFD
    K Number
    K083545
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ziehm Imaging, Inc.
    Date Received
    November 28, 2008
    Decision Date
    May 15, 2009
    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 Ziehm Imaging, Inc.

    K Number Device Name
    K092438 ZIEHM SOLO
    K073346 ZIEHM VISION 2
    K061310 ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM
    K061534 ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
    K061203 ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
    K051064 ZIEHM QUANTUM