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

    ZIEHM VISION 2

    K Number: K073346 · Decision Mar 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    7
    Review Days
    113

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    Basic Information

    Device Name
    ZIEHM VISION 2
    K Number
    K073346
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ziehm Imaging, Inc.
    Date Received
    November 29, 2007
    Decision Date
    March 21, 2008
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

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    Other Clearances by Ziehm Imaging, Inc.

    K Number Device Name
    K092438 ZIEHM SOLO
    K083545 ZIEHM VISION RFD
    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