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    Filters Country: Israel ×

    NAVIAID BGE DEVICE, MODEL 21-001

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    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