BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Revolution Apex Select

    Reg #: 2126677 · FEI: 2126677 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS, LLC
    Registration Number
    2126677
    FEI Number
    2126677
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3000 N GRANDVIEW BLVD.
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213715

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    Revolution Apex Select Revolution CT ES Revolution CT with Apex edition Revolution Apex Elite Revolution CT Power Revolution Apex Select with Elite Edition Revolution Apex Plus Revolution CT ES with Apex edition Revolution Apex Select with Plus Edition

    Establishment Types

    Manufacture Medical Device