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GE Healthcare Japan Corporation

Japan·JP-MF-000009291

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Optima CT660	Optima CT660	EUDAMED	Class IIb	Active
6Sc-D	H46462LS	EUDAMED	Class IIa	Active
Be9cs-Rs	H40482LN	EUDAMEDFDA UDI	Class IIa	Active
Be9cs-D	H40482LE	EUDAMEDFDA UDI	Class IIa	Active
Revolution Ascend Select	Revolution Ascend Select	EUDAMEDFDA UDI	Class IIb	Active
Ic5-9-D	H40442LK	EUDAMEDFDA UDI	Class IIa	Active
12l-Rs	H40402LY	EUDAMEDFDA UDI	Class IIa	Active
True Enhance DL	K233698	FDA 510(k)	Class II	Active
SIGNA Pioneer	K143345	FDA 510(k)	Class II	Active
Discovery Mr750w 3.0t	K103327	FDA 510(k)	Class II	Active
True Definition DL	K253686	FDA 510(k)	Class II	Active
Revolution Ascend	Revolution Ascend	EUDAMEDFDA UDI	Class IIb	Active
Deep Learning Image Reconstruction	5869275	EUDAMEDFDA UDI	Class IIa	Active
9l-Rs	H40442LL	EUDAMEDFDA UDI	Class IIa	Active
Ic5-9-D	H40442LK	EUDAMEDFDA UDI	Class IIa	Active
Revolution Ascend Elite	Revolution Ascend Elite	EUDAMEDFDA UDI	Class IIb	Active
C1-5-D	H40452LE	EUDAMEDFDA UDI	Class IIa	Active
Revolution Ascend Plus	Revolution Ascend Plus	EUDAMEDFDA UDI	Class IIb	Active
ASiR-V	5869273	EUDAMEDFDA UDI	Class IIa	Active
9l-D	H40442LM	EUDAMEDFDA UDI	Class IIa	Active
4Vc-D	H40482LS	EUDAMEDFDA UDI	Class IIa	Active
SmartMAR	5869274	EUDAMEDFDA UDI	Class IIa	Active
C1-5-Rs	H40462LA	EUDAMEDFDA UDI	Class IIa	Active
11l-D	5176269	EUDAMEDFDA UDI	Class IIa	Active
8c-Rs	H40402LS	EUDAMEDFDA UDI	Class IIa	Active

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Establishments registered with the FDA under this company group, matched by name.