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Sign in to claim this brandGE 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
- —
- —
- [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 4 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Leg'map Option | K973270 | FDA 510(k) | Class II | Active |
| Silhouette Fc | K993090 | FDA 510(k) | Class II | Active |
| Ge Logiq700 Diagnostic Ultrasound System With B-Flow | K990226 | FDA 510(k) | Class II | Active |
| Ge Mr Max | K912881 | FDA 510(k) | Class II | Active |
| Modification To 3.0t Signa Vh/I Magnetic Resonance System | K003575 | FDA 510(k) | Class II | Active |
| Ct Sytec 6000 Computed Tomography System | K921192 | FDA 510(k) | Class II | Active |
| Ge Sonochrome | K915138 | FDA 510(k) | Class II | Active |
| Innova 4100, Innova 3100 | K042053 | FDA 510(k) | Class II | Active |
| Advantage Windows Diagnostic X-Ray Workstation | K942120 | FDA 510(k) | Class II | Active |
| Millennium Mt And Millennium Mg Nuclear Medicine Systems | K962738 | FDA 510(k) | Class II | Active |
| Ge Signa Asset Imaging Option | K012970 | FDA 510(k) | Class II | Active |
| G.e. Sterile, Standard Biopsy Tray | K960141 | FDA 510(k) | Class II | Active |
| Signa 3.0t Magnetic Resonance System | K022397 | FDA 510(k) | Class II | Active |
| Senographic Stereo | K040125 | FDA 510(k) | Class II | Active |
| Computed Tomography X-Ray System | K970606 | FDA 510(k) | Class II | Active |
| Ge View Applications (consisting Of Ge Viewing Station And Ge Extended Viewing Station) Version 1.2c | K991629 | FDA 510(k) | Class II | Active |
| Mobile Ct Prospeed Family | K963896 | FDA 510(k) | Class II | Active |
| Ge System Five | K001267 | FDA 510(k) | Class II | Active |
| Quantem (tm) | K932957 | FDA 510(k) | Class I | Active |
| Diffusion Tensor Imaging Option | K003573 | FDA 510(k) | Class II | Active |
| Ge Propeller Imaging Option For Mri | K031230 | FDA 510(k) | Class II | Active |
| Ge Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging System | K000695 | FDA 510(k) | Class II | Active |
| Mobilix Mobile X-Ray Table | K945842 | FDA 510(k) | Class II | Active |
| Bp Trauma Air Pants | K841605 | FDA 510(k) | Class II | Active |
| Ge Logiq 9 Model 2375600 | K030934 | FDA 510(k) | Class II | Active |
| Ct Prospeed Ct/I | K961055 | FDA 510(k) | Class II | Active |
| Ge Logiq 200 Md Diagnostic Ultrasound System | K992208 | FDA 510(k) | Class II | Active |
| Accent 16, Accent 22 | K980322 | FDA 510(k) | Class II | Active |
| Patlak & Fdg Autoradiographic | K936001 | FDA 510(k) | Class II | Active |
| Magnetic Resonance Diagnostic Accessory | K944979 | FDA 510(k) | Class II | Active |
| Ge Mr Max System | K895794 | FDA 510(k) | Class II | Active |
| Ge 1.5t 8 Channel Torso Coil | K031209 | FDA 510(k) | Class II | Active |
| Xeleris 2 Processing And Review Workstation | K051673 | FDA 510(k) | Class II | Active |
| Hispeed X/I Smart Gantry Option | K012385 | FDA 510(k) | Class II | Active |
| 3.0t Signa Vh/I Magnetic Resonance System | K990550 | FDA 510(k) | Class II | Active |
| Lca Angiographic Imaging System | K941946 | FDA 510(k) | Class II | Active |
| Vivid 7 With Sonopac, Model Fb0008xx | K003931 | FDA 510(k) | Class II | Active |
| Dlx | K926258 | FDA 510(k) | Class II | Active |
| Attenuation Correction | K945652 | FDA 510(k) | Class II | Active |
| Ge Advantage Dicom Cr Reprocessing Station | K955185 | FDA 510(k) | Class II | Active |
| Tomo-Link | K944967 | FDA 510(k) | Class II | Active |
| Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera | K052434 | FDA 510(k) | Class II | Active |
| 8 Channel Cardiac Phased Array Coil | K032045 | FDA 510(k) | Class II | Active |
| Advantage Windows 3d Option And Dentascan Option | K923077 | FDA 510(k) | Class II | Active |
| Magnetic Resonance Diagnostic Accessory | K953595 | FDA 510(k) | Class II | Active |
| Ge Advantage Windows Review Workstation | K960613 | FDA 510(k) | Class II | Active |
| 3.0.t Signa Vh/I (t/R) Body Imaging Coil | K003613 | FDA 510(k) | Class II | Active |
| 8 Channel Cardiac Phased Array Coil | K022669 | FDA 510(k) | Class II | Active |
| Ge Lightspeed Act Fp16 | K091673 | FDA 510(k) | Class II | Active |
| Ct Hilight Advantage Ii | K904971 | FDA 510(k) | Class II | Active |
Related Companies
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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. |