BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Reg #: 3027338963 · FEI: 3027338963 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    125
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Registration Number
    3027338963
    FEI Number
    3027338963
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Andrei Sakharov St 9
    City
    Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K051673

    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
    System, Tomography, Computed, Emission KPS
    Cradle, Patient, Radiologic KXH
    System, X-Ray, Tomography, Computed JAK
    Camera, Scintillation (Gamma) IYX
    Holder, Head, Radiographic IWY
    Table, Radiographic, Non-Tilting, Powered IZZ
    Bed, Scanning, Nuclear IYZ

    Proprietary Names

    XELERIS 2 XELERIS XELERIS 2 PROCESSING AND REVIEW WORKSTATION PET Digital Gating MotionFree Xeleris V Processing and Review System NM600 INFANT SCAN SUPPORT Discovery PET/CT 710-64 Discovery PET/CT 710 Clarity Edition Discovery PET/CT 610 Discovery MI Digital Ready Discovery PET/CT 710 Clarity Brivo NM 615 Discovery MI Columbia Discovery MI Discovery Max Discovery MI Gen2 Discovery Max+ Discovery NM/CT 670 Pro Discovery NM/CT 670 ES NM/CT 870 DR Discovery NM/CT 670 Discovery 670 DR Millennium MPR Millennium MPR TF Millennium MPS PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS Discovery NM 750b Biopsy NM 830 Discovery NM 630 D670 HEAD HOLDER NG2000 ELITE HEAVY TABLE GT1700V(GT1700V N9 ED3, GT1700V) VT1700V(GT1700V N9 ED3) GT1700V (GT1700V N9 ED3, GT1700V) VT1700 (GT1700 N9 ED3) VT2000X(GT2000x) Lite (LITE TABLE N9 ED3, Lite Table) NG 2000 Table NM/CT Patient Table VT2000 (GT2000 N9 ED3) Kunlun Table NG2000V table G3 RAD Elevation Table Standard table NG1700 Patient Table Table (Model: GCTBL-C4) Table (Model: GCTBL-C33) NG LITE 1700 (NG1700 ELITE STANDARD TABLE) NG2000SV Table NG LITE 2000 (NG2000 ELITE HEAVY TABLE) NG2000SV TABLE NG1700 ELITE STANDARD TABLE Radiographic Table (Model: VFTBL-1) NG1700SV Table Table (Model: GCTBL-C3333) NG1700SV TABLE UFC-VCT Discovery NM/CT 570c GE DISCOVERY NM/CT 570C Volume Viewer Volume Viewer Apps Dynamic VUE Discovery VCT-RX Discovery VCT Discovery RX VCT Precision DL Discovery NM 750b NM Patient Table Discovery IQ Discovery IQ Clarity Disocvery PET/CT 610 Clarity Discovery PET/CT 690 Discovery PET/CT 600 Optima 560 / Discovery 690 Elite Discovery PET/CT 710 Optima PET/CT 560 Optima PET/CT 560FX Xeleris 4 Processing and Review Workstation Xeleris 4 DR Processing and Review Workstation Infinia Table for Infinia Systems INFINIA Infinia VC Hawkeye 4 Infinia Hawkeye 4 INFINIA VC GE QUASAR NUCLEAR MEDICINE SYSTEM Infinia Table Discovery NM/CT 670 CZT NM/CT 870 CZT Millennium MG MILLENNIUM MT NUCLEAR MEDICINE MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS Discovery MI Gen 2 Discovery Max Pro Discovery Future Discovery Power Ventri 1.1 Discovery NM 530c MyoSPECT MyoSPECT ES Ventri Optima NM/CT 640 Aurora IFINIA Hawkeye 4 INFINIA VC Hawkeye 4 HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA Xeleris 3.1 Volumetrix MI XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION DaTQUANT XELERIS 3 PROCESSING AND REVIEW WORKSTATION Xeleris 3 Clarify DL Max Elite Omni Legend Max Apollo StarGuide StarGuide Plus NM/CT 860 NM/CT 850 NM/CT 850 CT system NM/CT 860 CT system Max Apollo + Max Elite + MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility