BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    GE Medical Systems Israel, Functional Imaging

    Reg #: 3033524251 · FEI: 3033524251 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GE Medical Systems Israel, Functional Imaging
    Registration Number
    3033524251
    FEI Number
    3033524251
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Ha Peles 18
    City
    Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K243605

    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, X-Ray, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    Aurora StarGuide StarGuide Plus NM/CT 860 NM/CT 850 NM/CT 850 CT system NM/CT 860 CT system Discovery NM/CT 670 Pro Discovery NM/CT 670 ES NM/CT 870 DR Discovery NM/CT 670 Discovery 670 DR Discovery NM/CT 670 CZT NM/CT 870 CZT NM 830 Discovery NM 630 Optima NM/CT 640 MyoSPECT MyoSPECT ES

    Establishment Types

    Manufacture Medical Device