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GE Medical Systems, LLC

United States·US-MF-000001632

Last updated September 17, 2026

Information

Country: United States
Address: 3000, N Grandview Blvd, Waukesha, United States
Website: gehealthcare.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Chris Paulik
EUDAMED SRN: US-MF-000001632
FDA FEI Number: 2183553
DUNS Number: —

Catalogue (100)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Spectral Color Overlay	5929649	EUDAMEDFDA UDI	Class IIa	Active
5” Round Coil 1.5T	2127316	EUDAMEDFDA UDI	Class I	Active
3d Asl	K092925	FDA 510(k)	Class II	Active
Discovery Ct750 Hd	K120833	FDA 510(k)	Class II	Active
Discovery Xr656 With Volumerad (digital Tomosynthesis)	K132261	FDA 510(k)	Class II	Active
Photonova Spectra, Photonova Spectra Select	K253520	FDA 510(k)	Class II	Active
SIGNA™ Sprint Select	K253779	FDA 510(k)	Class II	Active
Innova 2121iq, Innova 3131iq, Innova 4100, Innova 4100iq, Innova 3100, Innova 3100iq, Innova 2100iq With Innova Ivus Opt	K061163	FDA 510(k)	Class II	Active
Wireless Dr Imaging Option-Wdr1	K102615	FDA 510(k)	Class II	Active
Discovery Mr750 3.0t , Discovery Mr450 1.5t, Discovery Mr750 3.0t, Optima Mr450w 1.5t	K142085	FDA 510(k)	Class II	Active
Deep Learning Image Reconstruction for Gemstone Spectral Imaging	K201745	FDA 510(k)	Class II	Active
Ge Xtreme Injector Option	K082960	FDA 510(k)	Class II	Active
ECG-less Cardiac	K233750	FDA 510(k)	Class II	Active
Brivoxr285amx, Optima Xr200amx, Optimaxr220amx	K103476	FDA 510(k)	Class II	Active
Ge 0.7t Signa Openspeed With Excite Mr System	K032795	FDA 510(k)	Class II	Active
HyperBand	K162403	FDA 510(k)	Class II	Active
Sonic DL	K243667	FDA 510(k)	Class II	Active
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite	K223491	FDA 510(k)	Class II	Active
Revolution Xr/D Digital Radiographic Imaging System With Manual Image Pasting	K042602	FDA 510(k)	Class II	Active
Signa 3.0t Mr750 System	K081028	FDA 510(k)	Class II	Active
Ge Signa Mr Oncology Package	K081916	FDA 510(k)	Class II	Active
Discovery Ct 590 Rt, Optima Ct 580, Optima Ct 580 Rt, Optima Ct 580 W	K132410	FDA 510(k)	Class II	Active
SIGNA™ Sprint	K251399	FDA 510(k)	Class II	Active
Critical Care Suite with Enteric Tube Positioning AI Algorithm	K253502	FDA 510(k)	Class II	Active
Ge Lightspeed Xtra Ct Scanner System	K060052	FDA 510(k)	Class II	Active
MAGiC	K161397	FDA 510(k)	Class II	Active
Critical Care Suite with Endotracheal Tube Positing AI algorithm	K211161	FDA 510(k)	Class II	Active
Ge Signa Profile 6 Inch Gp Coil	K041921	FDA 510(k)	Class II	Active
Mr-Touch Option	K083421	FDA 510(k)	Class II	Active
Mr Radiation Oncology Options	K102155	FDA 510(k)	Class II	Active
Optima Pet/Ct 560	K081496	FDA 510(k)	Class II	Active
1.5t Optima Mr430s	K103238	FDA 510(k)	Class II	Active
Lightspeed 7.1 Ct Scanner System	K061817	FDA 510(k)	Class II	Active
Brainstat Software Option For Ge Signa Mr Scanner	K073167	FDA 510(k)	Class II	Active
SIGNA™ Bolt	K253780	FDA 510(k)	Class II	Active
Optima Mr450w	K113490	FDA 510(k)	Class II	Active
1.5 Ge 6-Channel Phased Array Flex Coil, 3.0 Ge 6-Channel Phased Array Flex Coil	K110610	FDA 510(k)	Class II	Active
Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121	K060259	FDA 510(k)	Class II	Active
Ge Lightspeed 7.2 Ct Scanner System	K082761	FDA 510(k)	Class II	Active
Low Dose CT Lung Cancer Screening Option for Qualified GE Systems	K151372	FDA 510(k)	Class II	Active
Ge Signa Excite 1.5t Mr System, Ge Signa Excite 3.0t Mr System	K041476	FDA 510(k)	Class II	Active
Cardiac Vx	K121762	FDA 510(k)	Class II	Active
Optima XR240amx	K182234	FDA 510(k)	Class II	Active
1.5t Signa Hdxt 3.0t Signa Hdxt Signa Vibrant	K121676	FDA 510(k)	Class II	Active
Asir-V	K133640	FDA 510(k)	Class II	Active
Deep Learning Image Reconstruction	K213999	FDA 510(k)	Class II	Active
Lightspeed 7.0 Ct Scanner System	K040372	FDA 510(k)	Class II	Active
Discovery MI	K161574	FDA 510(k)	Class II	Active
Optima Ct660	K131576	FDA 510(k)	Class II	Active
Lightspeed 6.0 Ct Scanner System	K033502	FDA 510(k)	Class II	Active

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GE Medical Systems SCS FR

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FDA Recalls (5)

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
Apr 20, 2026	Z-2318-2026	—	open, classified	GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Apr 20, 2026	Z-2317-2026	—	open, classified	GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Apr 20, 2026	Z-2315-2026	—	open, classified	GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Apr 20, 2026	Z-2314-2026	—	open, classified	GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Apr 20, 2026	Z-2316-2026	—	open, classified	GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.