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

    XRpad2 4343 HWC-M Flat Panel Detector

    K Number: K181526 · Decision Jul 3, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    7
    Review Days
    22

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    Basic Information

    Device Name
    XRpad2 4343 HWC-M Flat Panel Detector
    K Number
    K181526
    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
    June 11, 2018
    Decision Date
    July 3, 2018
    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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