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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 5 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Neurocam | K910967 | FDA 510(k) | Class I | Active |
| Advantx Afm Angio System S1808 | K905653 | FDA 510(k) | Class II | Active |
| G.e. Sterile Breast Biopsy/Localization Tray | K960201 | FDA 510(k) | Class II | Active |
| Advantage Windows X-Ray/Mr Fusion | K022310 | FDA 510(k) | Class II | Active |
| Stenoscop Mobile Fluoroscopic Xray System | K933447 | FDA 510(k) | Class II | Active |
| Innova 3100 | K031637 | FDA 510(k) | Class II | Active |
| Ct Hilight Advantage | K894269 | FDA 510(k) | Class II | Active |
| Ge Logiq 700 | K001016 | FDA 510(k) | Class II | Active |
| Magnetic Resonance Diagnostic Device | K913475 | FDA 510(k) | Class II | Active |
| Compact Digital Cardiac Camera (cdcc) | K033199 | FDA 510(k) | Class II | Active |
| Signa Profile Wrist Coil And Mobile Siting Options | K971668 | FDA 510(k) | Class II | Active |
| Magnetic Resonance Diagnostic Device | K903319 | FDA 510(k) | Class II | Active |
| Fil 1520 | K101629 | FDA 510(k) | Class II | Active |
| Cardiac Phased Array Coil | K971667 | FDA 510(k) | Class II | Active |
| Silhouette Vr | K982955 | FDA 510(k) | Class II | Active |
| G.e. Sterile Amniocentesis Tray | K960203 | FDA 510(k) | Class I | Active |
| Innova 4100 | K023178 | FDA 510(k) | Class II | Active |
| Magellan | K940300 | FDA 510(k) | Class II | Active |
| Logiq A200 Diagnostic Ultrasound System | K960700 | FDA 510(k) | Class II | Active |
| Ct Sytec 4000 | K911387 | FDA 510(k) | Class II | Active |
| Signa Sp Crown Coils (numbers 1 Through 3) | K964969 | FDA 510(k) | Class II | Active |
| Vascular Mp X-Ray Generator | K943652 | FDA 510(k) | Class I | Active |
| Revolution Tx/I Digital Radiographic Table System | K992066 | FDA 510(k) | Class II | Active |
| Ct Colonography/Navigator2 | K012313 | FDA 510(k) | Class II | Active |
| High Impedance Cardiac Gating Cable | K981190 | FDA 510(k) | Class II | Active |
| Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil | K982772 | FDA 510(k) | Class II | Active |
| 3.0t Torso Phased Array Coil | K030495 | FDA 510(k) | Class II | Active |
| Signa Advantage 0.5t Magnetic Resonance System | K912539 | FDA 510(k) | Class II | Active |
| Magnetic Resonance Diagnostic System | K950973 | FDA 510(k) | Class II | Active |
| Ge Logiq 700 Diagnostic Ultrasound System | K964886 | FDA 510(k) | Class II | Active |
| Magnetic Resonance Diagnostic Accessory | K934499 | FDA 510(k) | Class II | Active |
| Signa Profile/I Magnetic Resonance System | K992135 | FDA 510(k) | Class II | Active |
| Signa Mfo/I Magnetic Resonance System | K002611 | FDA 510(k) | Class II | Active |
| Srs Vaginal Emg/Stimulation Perineometer Sensor Srs Anal Emg/Stimulation Perineometer Sensor | K002834 | FDA 510(k) | Class II | Active |
| Advantx 1824 Spotfilm Device | K950317 | FDA 510(k) | Class II | Active |
| Ge Vivid 7 With Or Without Suffix | K051449 | FDA 510(k) | Class II | Active |
| Sage 7 | K984167 | FDA 510(k) | Class II | Active |
| Hispeed Dual | K021491 | FDA 510(k) | Class II | Active |
| Prostate Spectroscopy And Imaging Exam (prose) Software Option For Mri | K011604 | FDA 510(k) | Class II | Active |
| Target 2 Version 1.1 | K965010 | FDA 510(k) | Class II | Active |
| Innova And Innova 2000 S | K022322 | FDA 510(k) | Class II | Active |
| Ge Sterile Arthrogram Tray | K962035 | FDA 510(k) | Class II | Active |
| Ct Colonography | K023943 | FDA 510(k) | Class II | Active |
| Ct/E Computed Tomography Scannner System | K993645 | FDA 510(k) | Class II | Active |
| Dual Energy And Tissue Equalization Software Option | K013481 | FDA 510(k) | Class II | Active |
| Ligthspeed 3.0 Ct Scanner System | K002978 | FDA 510(k) | Class II | Active |
| Advantage Windows (aw) Fusion | K983256 | FDA 510(k) | Class II | Active |
| Ideal Iq Software Option | K103411 | FDA 510(k) | Class II | Active |
| Senographe Pearl And Senographe Sapphire | K953250 | FDA 510(k) | Class II | Active |
| Smart Breath Respiratory Compensation Option | K022919 | 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. |