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

    Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)

    K Number: K161459 · Decision Sep 6, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    2
    Review Days
    103

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    Basic Information

    Device Name
    Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
    K Number
    K161459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Varian Medical Systems, X-Ray Products-Infimed
    Date Received
    May 26, 2016
    Decision Date
    September 6, 2016
    Product Code
    MQB
    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
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

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    Other Clearances by Varian Medical Systems, X-Ray Products-Infimed

    K Number Device Name
    K130318 NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)