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GE MEDICAL SYSTEMS, INC.

United States·US-MF-000001632

Last updated September 17, 2026

What GE MEDICAL SYSTEMS, INC. makes

The company manufactures stationary and mobile digital X-ray systems, including mammographic and angiographic units, as well as full-body computed tomography (CT) scanners and positron emission tomography (PET) systems. Their portfolio also includes MRI radio-frequency coils, indirect flat-panel X-ray detectors, and software for X-ray image interpretation.

These devices are regulated under various classifications, including Class I, Class II, Class IIa, Class IIb, and Class III, and are listed in the EUDAMED database, FDA’s 510(k), PMA, and UDI registries. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 3000, N Grandview Blvd, Waukesha, United States
Website: gehealthcare.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(999)999-9999
PRRC Contact: Chris Paulik
EUDAMED SRN: US-MF-000001632
FDA FEI Number: 2126677
DUNS Number: 809785715

Catalogue (373)

Page 3 of 8

Device	Model / Reference	Registries	Class	Status
Revolution	CT with Quantix Upgrade	FDA UDI	Class II	Active
Innova	UPG X100 001	FDA UDI	Class II	Unknown
Allia	IGS 3	FDA UDI	Class II	Active
Allia	IGS 7 OR	FDA UDI	Class II	Active
UroCuff-DC Disposable, Single	730-002	FDA UDI	Class II	Active
Pristina Serena	KAS1	FDA UDI	Class II	Active
Flashpad HD	3543	FDA UDI	Class II	Active
Horizontal	JMM1	FDA UDI	Class II	Active
Radiation Screen	LMP1	FDA UDI	Class I	Active
Insight Discovery Algometer	900-015-2	FDA UDI	Class II	Active
Uroflow Scale	900-035	FDA UDI	Class II	Active
EMG Sensor	900-026	FDA UDI	Class II	Active
EasyPro One	900-038	FDA UDI	Class II	Active
Discovery	IGS 730 001	FDA UDI	Class II	Unknown
EasyFlo Console	900-044	FDA UDI	Class II	Active
EasyFlo Scale	84411318	FDA UDI	Class II	Active
Critical Care Suite	PACS 1.0	FDA UDI	Class II	Active
Critical Care Suite	1.0	FDA UDI	Class II	Active
The Spanner Temporary Prostatic Stent	The Spanner Stent Size 5	FDA UDI	Class III	Active
Senographe Pristina 3D	ATA2	FDA UDI	Class III	Active
Pristina Paddle	SLD LS	FDA UDI	Class I	Active
Pristina Paddle	19X23SLD	FDA UDI	Class I	Active
CT3000Plus Base Unit	900-031	FDA UDI	Class II	Active
Pristina Paddle	24x29 FLEX	FDA UDI	Class I	Active
1.5T HDxt Upgrade Kit	1.5T HDxt Upgrade Kit	EUDAMED	Class IIa	Active
3” Round Coil 1.5T	2127315	EUDAMEDFDA UDI	Class I	Active
Revolution Apex Elite	5590000-23	EUDAMEDFDA UDI	Class IIb	Active
AMX Navigate UPGRADE	5844925-1	EUDAMEDFDA UDI	Class IIb	Active
Dielectric Pad - Neck	5790189 (E8823JD, E8823JF)	EUDAMED	Class I	Active
Revolution Apex Plus	5590000-25	EUDAMEDFDA UDI	Class IIb	Active
DV GOC Upgrade Console	DV GOC Upgrade Console	EUDAMED	Class IIa	Active
Magnetic Resonance Diagnostic System	K964370	FDA 510(k)	Class II	Active
Magnetic Resonance Diagnostic System	K963179	FDA 510(k)	Class II	Active
Mph50, Mph65, And Mph80	K954666	FDA 510(k)	Class I	Active
Advantage Workstation 4.1	K020483	FDA 510(k)	Class II	Active
Lightspeed 4.0 Ct Scanner System	K013561	FDA 510(k)	Class II	Active
Ge Target Series 2	K896353	FDA 510(k)	Class II	Active
Solarix Fv	K953832	FDA 510(k)	Class II	Active
Functional Brain Mapping Option For Mri	K003947	FDA 510(k)	Class II	Active
G.e. Sterile Digital Angiographic Tray	K960143	FDA 510(k)	Class I	Active
Advantage 3d Xr	K974715	FDA 510(k)	Class II	Active
Advantx Lca	K945375	FDA 510(k)	Class II	Active
Orion Platinum	K003367	FDA 510(k)	Class II	Active
Ge Logiq 700 With Coded Excitation Modification	K993364	FDA 510(k)	Class II	Active
Ge Logiq 700	K000571	FDA 510(k)	Class II	Active
Spectef Protocol	K954874	FDA 510(k)	Class II	Active
Ge Signa Excite 1.5t 6 Channel Phased Array Flex Coil, Ge Signa Excite 3.0t 6 Channel Phased Array Flex Coil	K042844	FDA 510(k)	Class II	Active
Extra Large Body Coil	K023442	FDA 510(k)	Class II	Active
Hispeed Ct/I With Performix Tube And Warp Scan Option	K964746	FDA 510(k)	Class II	Active
Smart Vessel Analysis (smart Va) Option	K993792	FDA 510(k)	Class II	Active

Related Companies

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Authorities

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FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 16, 2020	Z-0569-2021	—	terminated	Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.
Jul 24, 2020	Z-0050-2021	—	terminated	Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
Jan 23, 2020	Z-2497-2020	—	terminated	A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.
Sep 19, 2019	Z-2006-2020	—	terminated	The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.
Aug 23, 2019	Z-1631-2020	—	terminated	At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease firing as long as the foot pedal or handpiece switch is depressed. This malfunction can cause overtreatment, which could result in strong erythema, and possibly cause blisters.
Feb 15, 2018	Z-2218-2019	—	terminated	Lasers/Catheters did not calibrate during set-up prior to use.
Jun 30, 2014	Z-2123-2014	—	terminated	RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed.