BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ICX Series, INX Series

    Reg #: 1483291 · FEI: 1483291 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Varex Imaging Americas Corporation
    Registration Number
    1483291
    FEI Number
    1483291
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3835 Carnation St
    City
    Franklin Park
    State
    IL
    ZIP
    60131
    Country
    US

    Owner / Operator

    Firm Name
    Varex Imaging Corporation
    Operator Number
    10053550
    Address
    1678 South Pioneer Road
    City
    Salt Lake City
    State
    UT
    Postal Code
    84104
    Country
    US

    Products

    Device Name Product Code
    Generator, High-Voltage, X-Ray, Diagnostic IZO

    Proprietary Names

    ICX Series, INX Series SolidStateMC 501 Series SolidStateMC 510 Series SolidStateMC 601 Series SolidStateMC 613 Series SolidStateMC 619 Series SolidStateMC 609 Series SolidStateMC 502 Series AmpMC 1002 Series AmpMC 1006 Series AmpMC 1008 Series SolidStateMC 508 Series SolidStateMC 506 Series SolidStateMC 625 Series SolidStateMC 621 Series AmpMC 1012 Series SolidStateMC 610 Series SolidStateMC 614 Series AmpMC 1007 Series SolidStateMC 616 Series AmpMC 1001 Series SolidStateMC 617 Series SolidStateMC 521 Series SolidStateMC 605 Series

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198