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GE Medical Systems Israel, Functional Imaging

Israel·IL-MF-000003062

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Nm/Ct 870 Dr	H3906FZ, H3906GA, H3906GB, H3906GC, H3906GD, H3906GE	EUDAMEDFDA UDI	Class IIb	Active
Discovery Nm 750b	K102231	FDA 510(k)	Class I	Active
Clarify DL	K241350	FDA 510(k)	Class II	Active
Omni Legend	K241665	FDA 510(k)	Class II	Active
Xeleris 4 DR Processing & Review Workstation	5782764	EUDAMEDFDA UDI	Class IIa	Active
StarGuide GX	H3911BW	EUDAMED	Class IIb	Active
Omni	PCM-PET0014	EUDAMED	Class IIb	Active
MyoSPECT	H3912BC	EUDAMEDFDA UDI	Class IIa	Active
Nm 830	H3910AY, H3910AZ and H3910BA	EUDAMEDFDA UDI	Class IIa	Active
Nm/Ct 850	H3907BC, H3907BD, H3907BH, H3907BJ, H3907BG, H3907BK	EUDAMEDFDA UDI	Class IIb	Active
Xeleris V Processing & Review System	5927911	EUDAMED	Class IIa	Active
MyoSPECT ES	H3912BD	EUDAMEDFDA UDI	Class IIa	Active
Nm/Ct 870 Czt	H3906EX , H3906EW	EUDAMED	Class IIb	Active
StarGuide MDD to MDR Upgrade	5962426	EUDAMEDFDA UDI	Class IIb	Active
StarGuide	H3911AA	EUDAMEDFDA UDI	Class IIb	Active
StarGuide	H3911BH	EUDAMEDFDA UDI	Class IIb	Active
DaTQUANT	H3901ZD	EUDAMEDFDA UDI	Class IIa	Active
Aurora	Aurora-NM-PCM	EUDAMEDFDA UDI	Class IIb	Active
Nm/Ct 860	H3908BF, H3908BG, H3908BK, H3908BL, H3908BM, H3908BN	EUDAMEDFDA UDI	Class IIb	Active
MyoSPECT ES to MyoSPECT Upgrade	H3912BS	EUDAMEDFDA UDI	Class IIa	Active
StarGuide to StarGuide with dsCZT Detectors	H3911CF	EUDAMED	Class IIb	Active

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