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

    Nexus DR Digital X-Ray Imaging System (with vSharp)

    K Number: K193238 · Decision Dec 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    7
    Review Days
    25

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    Basic Information

    Device Name
    Nexus DR Digital X-Ray Imaging System (with vSharp)
    K Number
    K193238
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Varex Imaging Corporation
    Date Received
    November 25, 2019
    Decision Date
    December 20, 2019
    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 Varex Imaging Corporation

    K Number Device Name
    K253103 Nexus DRF Digital X-ray Imaging System
    K190146 Nexus DR Digital X-ray Imaging System
    K183212 Nexus DR Digital X-ray Imaging System with stitching
    K181526 XRpad2 4343 HWC-M Flat Panel Detector
    K172951 Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)
    K171138 Nexus DR Digital X-ray Imaging System