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Sign in to claim this brandGE Medical Systems, LLC
United States·US-MF-000001632
Last updated September 17, 2026
What GE Medical Systems, LLC makes
GE Medical Systems, LLC manufactures MRI system coils, including radio-frequency components like the 5” Round Coil for 1.5T systems, as well as full-body CT imaging solutions such as the DISCOVERY CT750 HD and the DISCOVERY XR656 with Volumerad digital tomosynthesis. Their portfolio also includes advanced MRI technologies like the SIGNA Sprint Select, INNOVA series intravascular ultrasound (IVUS) systems, and spectral imaging tools such as Spectral Color Overlay and Photonova Spectra variants. Additional offerings include wireless DR imaging options, deep learning-based image reconstruction for spectral imaging, and high-performance injectors like the GE XTREME Injector Option.
The company’s devices are classified under FDA categories including Class I, Class II, Class IIa, and Class IIb, with corresponding entries in the FDA’s 510(k) registry and the EU’s eudamed database. These regulatory listings reflect the authorised status of individual products under applicable medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does GE Medical Systems, LLC primarily manufacture?
GE Medical Systems, LLC specialises in two main categories: MRI system coils, including radio-frequency components like the 5” Round Coil for 1.5T systems, and full-body CT imaging systems such as the DISCOVERY CT750 HD and DISCOVERY XR656 with Volumerad digital tomosynthesis. Their portfolio also includes advanced MRI technologies, intravascular ultrasound (IVUS) systems, spectral imaging tools, wireless DR imaging options, and high-performance injectors. These devices are designed for diagnostic imaging and procedural guidance in clinical settings.
Where is GE Medical Systems, LLC based, and does this affect its regulatory listings?
GE Medical Systems, LLC is based in the United States. This location influences its regulatory listings, as the company’s devices are authorised under U.S. FDA regulations (e.g., 510(k) submissions) and the EU’s eudamed database. The FDA’s 510(k) registry and eudamed reflect the authorised status of individual devices under their respective jurisdictions, ensuring compliance with regional medical device regulations.
Which regulatory registries list devices manufactured by GE Medical Systems, LLC?
Devices from GE Medical Systems, LLC are listed in two key regulatory registries: the FDA’s 510(k) database in the United States and the EU’s eudamed system. These registries document the authorised status of specific devices under their respective medical device frameworks, ensuring transparency for healthcare providers, regulators, and other stakeholders.
How are the devices manufactured by GE Medical Systems, LLC classified under medical device regulations?
The devices produced by GE Medical Systems, LLC fall into multiple FDA classification categories: Class I (generally low-risk), Class II (moderate-risk with special controls), Class IIa (a subset of Class II with specific regulatory requirements), and Class IIb (higher-risk Class II devices). The classification determines the regulatory pathway for authorisation, with higher-risk devices requiring more rigorous pre-market evaluation to ensure safety and effectiveness.
Why do some devices from GE Medical Systems, LLC appear in both the FDA’s 510(k) registry and eudamed?
Devices appear in both registries because they are authorised for use in both the United States and the European Economic Area (EEA). The FDA’s 510(k) registry tracks devices cleared under U.S. regulations, while eudamed lists devices authorised under EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). This dual listing reflects the company’s global market presence and compliance with regional requirements for each authorised device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 3000, N Grandview Blvd, Waukesha, United States
- Website
- gehealthcare.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Chris Paulik
- EUDAMED SRN
- US-MF-000001632
- FDA FEI Number
- 2183553
- DUNS Number
- —
Catalogue (100)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Deep Learning Image Reconstruction | K183202 | FDA 510(k) | Class II | Active |
| Discovery Model Ct590 Rt And Optima Model Ct580 Ct Systems | K093581 | FDA 510(k) | Class II | Active |
| Signa Magnus | K241242 | FDA 510(k) | Class II | Active |
| Critical Care Suite | K183182 | FDA 510(k) | Class II | Active |
| Ge Brightspeed Delight Ct Scanner System | K082816 | FDA 510(k) | Class II | Active |
| Ideal Software Option For Ge Mr Scanners | K072998 | FDA 510(k) | Class II | Active |
| Optima XR240amx, AutoGrid | K173602 | FDA 510(k) | Class II | Active |
| Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T | K160618 | FDA 510(k) | Class II | Active |
| Discovery Pet/Ct 710 | K133657 | FDA 510(k) | Class II | Active |
| Optima XR240amx | K162990 | FDA 510(k) | Class II | Active |
| Cortex Id Suite | K141074 | FDA 510(k) | Class II | Active |
| Mavric Sl | K113394 | FDA 510(k) | Class II | Active |
| Advantage 4d Option | K032915 | FDA 510(k) | Class II | Active |
| Brivo Xr385 | K103448 | FDA 510(k) | Class II | Active |
| PET Digital Gating | K180318 | FDA 510(k) | Class II | Active |
| Optima Ct660 | K110227 | FDA 510(k) | Class II | Active |
| Precision Thunis 800+ | K061028 | FDA 510(k) | Class II | Active |
| AMX Navigate | K210982 | FDA 510(k) | Class II | Active |
| Innova Ct Option For Digital Fluoroscopic Imaging Systems Innova Models 4100, 4100iq, 3100, 3100iq & 2100iq | K052157 | FDA 510(k) | Class II | Active |
| Optima Mr 430s | K123068 | FDA 510(k) | Class II | Active |
| SIGNA Prime Elite | K250379 | FDA 510(k) | Class II | Active |
| Q. Freeze (motion Vue2) | K113408 | FDA 510(k) | Class II | Active |
| Optima Xr120 | K111304 | FDA 510(k) | Class II | Active |
| HyperSense | K162722 | FDA 510(k) | Class II | Active |
| Customer Remote Console (CRC) | K150193 | FDA 510(k) | Class II | Active |
| AIR Recon DL | K252379 | FDA 510(k) | Class II | Active |
| Discovery MI Gen2 | K211846 | FDA 510(k) | Class II | Active |
| Optima XR200amx, Optima XR220amx | K142383 | FDA 510(k) | Class II | Active |
| Optima Mr450w | K091536 | FDA 510(k) | Class II | Active |
| Innova 2100 | K050489 | FDA 510(k) | Class II | Active |
| Ge 1.5t Signa Hde Mr System | K052978 | FDA 510(k) | Class II | Active |
| Fcp | 5437192 | EUDAMED | Class I | Active |
| Discovery Mr 450- 1.5t Split Head Coil | 5182594 | EUDAMEDFDA UDI | Class IIa | Active |
| SIGNA Premier | SIGNA Premier | EUDAMEDFDA UDI | Class IIa | Active |
| Revolution UPG 3 | Revolution UPG3 | EUDAMEDFDA UDI | Class IIb | Active |
| Discovery IQ | PCM-PET0008A | EUDAMEDFDA UDI | Class IIb | Active |
| 1.5T GE 6-Channel Phased Array Flex Coil | 5363383 | EUDAMEDFDA UDI | Class I | Active |
| SIGNA Pioneer | SIGNA Pioneer | EUDAMEDFDA UDI | Class IIa | Active |
| Signa Pet/Mr | SIGNA PET/MR | EUDAMEDFDA UDI | Class IIa | Active |
| SIGNA Architect | SIGNA Architect | EUDAMEDFDA UDI | Class IIa | Active |
| Revolution CT ES with Apex edition | Revolution CT ES with Apex edition | EUDAMEDFDA UDI | Class IIb | Active |
| Omni Legend | PCM-PET0012 | EUDAMEDFDA UDI | Class IIb | Active |
| Head Auto Views | 5988228 | EUDAMED | Class IIa | Active |
| SIGNA Hero | SIGNA Hero | EUDAMEDFDA UDI | Class IIa | Active |
| Performix Pulsar | 5886600 | EUDAMED | Class IIb | Active |
| SnapShot Freeze 2 | 5807631 | EUDAMEDFDA UDI | Class IIa | Active |
| Performix HD Plus | 5970000 | EUDAMED | Class IIb | Active |
| Revolution CT | 5595000-61 | EUDAMEDFDA UDI | Class IIb | Active |
| Spectral Bone Marrow | 5973667 | EUDAMEDFDA UDI | Class IIa | Active |
| 3.0T GE 6-Channel Phased Array Flex Coil | 5363393 | EUDAMEDFDA UDI | Class I | Active |
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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.
GE Medical Systems, LLC has five recall records initiated on April 20, 2026, all related to a potential electrical issue with an electrical cable on certain IGS systems equipped with Gaia generators. The recalls are marked with open and classified statuses, and the reason stated involves a risk of electrical shock to service personnel during installation, maintenance, or troubleshooting inside the C-FRT cabin.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| 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. |