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    GE Medical Systems Israel", Functional Imaging

    Manufacturer
    🇮🇱 Israel·6 Basic UDI-DIs·8 Devices·GMED SAS

    GE MEDICAL SYSTEMS Israel Ltd.

    Manufacturer
    🇮🇱 Israel

    CT/GAMMA CAMERA SYSTEMS

    Device
    EU MDR · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·On the market·32 countries

    MyoSPECT ES

    Device
    EU MDR · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·On the market·32 countries

    MyoSPECT

    Device
    EU MDR · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·On the market·23 countries

    Aurora

    Device
    EU MDR · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·On the market·2 countries

    Xeleris V Processing & Review System

    Device
    EU MDR · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·On the market·32 countries

    StarGuide MDD to MDR Upgrade

    Device
    EU MDR · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·On the market·32 countries

    StarGuide

    Device
    EU MDD · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·On the market·32 countries

    MyoSPECT

    Device
    EU MDD · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·On the market·32 countries

    Aurora

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·1 device

    StarGuide

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·2 devices

    MyoSPECT

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·2 devices

    Xeleris V Processing and Review System

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·1 device

    StarGuide

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·1 device

    MyoSPECT

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·1 device

    7927

    Certificate
    MDD Annex II (excluding section 4)·GE Medical Systems Israel", Functional Imaging·GMED SAS·2 Basic UDI-DIs

    Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS, ISRAEL LTD.·October 11, 2023

    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026

    SMV DSI, System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026