BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Volumetrix MI

    Reg #: 3027338963 · FEI: 3027338963 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Registration Number
    3027338963
    FEI Number
    3027338963
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Andrei Sakharov St 9
    City
    Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K130884

    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

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Volumetrix MI Xeleris 3.1 XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION DaTQUANT

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility