57 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Israel
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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
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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
MAXXUS, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
SMV BodyTrack, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026