Data / Medical devices / France / Ge Medical Systems SCS
Ge Medical Systems SCS: FDA-registered device maker in Buc, France, 115 510(k) clearances and 2 PMA approvals
Ge Medical Systems SCS is registered with the FDA (registration 9611343) in Buc, France. It lists 19 device types. The FDA files 115 510(k) clearances and 2 PMA approvals under its listings, the newest dated July 21, 2026. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9611343
- FEI number
- 1000284313
- Address
- 283 Rue De La Miniere, Buc, France, 78530
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- October 6, 1999
- Registered through
- 2027
- Brand names listed
- 10x23, 19x23, 24x29, 2DLoc, 2DLocP, 3DStent, 3DXR, 40782 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 115.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 21, 2026 | K253770 | CardIQ Suite | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| March 24, 2026 | K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | MUE | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| December 9, 2025 | K251199 | Allia Moveo | OWB | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| June 18, 2025 | K243672 | CardIQ Suite | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| April 21, 2025 | K243651 | VersaViewer | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| February 25, 2025 | K243446 | 3DXR | OWB | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| August 1, 2024 | K233731 | CardIQ Suite | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| January 25, 2024 | K233714 | BreView | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| October 11, 2023 | K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | OWB | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| July 13, 2023 | K223424 | Spine Auto Views | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| March 21, 2023 | K223490 | FlightPlan for Embolization | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| March 9, 2023 | K223514 | Spectral Bone Marrow | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 22, 2022 | K223152 | Vision 2, EVARVision, TrackVision 2, HeartVision 2 | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| November 22, 2022 | K222895 | DynamicIQ | KPS | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| May 2, 2022 | K211180 | Liver Suite | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| March 11, 2022 | K213725 | CardIQ Suite | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| October 22, 2021 | K210807 | FlightPlan for Liver | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| August 6, 2021 | K211725 | Senographe Pristina | MUE | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| July 27, 2021 | K211247 | PET VCAR | KPS | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| June 22, 2021 | K211215 | SenoBright HD | MUE | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 16, 2021 | K200626 | VesselIQ Xpress | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| November 17, 2020 | K193306 | PROView | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| November 12, 2020 | K193289 | FastStroke, CT Perfusion 4D | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| May 15, 2020 | K193334 | Pristina Serena Bright | MUE | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 20, 2020 | K193281 | Hepatic VCAR | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| February 14, 2020 | K192277 | CardIQ Flow | KPS | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| January 24, 2020 | K193261 | FlightPlan for Embolization | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| October 24, 2019 | K192686 | Revolution Maxima, Revolution Ace | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| July 29, 2019 | K190809 | Sample Imaging for Senographe Pristina | MUE | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 8, 2019 | K183204 | Bone VCAR (BVCAR) | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| March 29, 2019 | K183210 | Thoracic VCAR with GSI Pulmonary Perfusion | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| February 13, 2019 | K183161 | SnapShot Freeze 2 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 18, 2019 | K182951 | Pristina Serena 3D | MUE | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 2, 2018 | K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| May 14, 2018 | K173576 | Pristina Serena | MUE | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 24, 2018 | K180225 | GSI Viewer with GSI Fat Option | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| October 30, 2017 | K172404 | SenoBright HD | MUE | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 1, 2017 | K163302 | Senographe Pristina | MUE | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| January 26, 2017 | K163281 | FastStroke | JAK | Substantially Equivalent | Gef Medical Systems Scs | accessdata.fda.gov |
| November 3, 2016 | K162268 | Senographe Pristina | MUE | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 31, 2016 | K161397 | MAGiC | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 1, 2016 | K160937 | Senolris | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| January 20, 2016 | K152584 | Stroke VCAR | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| January 20, 2016 | K152352 | Stereo 3D option for Vision Applications | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| July 29, 2015 | K143368 | GenIQ | LLZ | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 18, 2014 | K141074 | CORTEX ID SUITE | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 24, 2014 | K133278 | DISCOVERY IGS 740 | OWB | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| April 22, 2014 | K133649 | HEPATIC VCAR | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| March 14, 2014 | K132944 | ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION | KPQ | Substantially Equivalent | Ge Hungary Kft | accessdata.fda.gov |
| September 26, 2013 | K131885 | SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) | MUE | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| September 4, 2013 | K132045 | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS | KPQ | Substantially Equivalent | Ge Hungary Kft | accessdata.fda.gov |
| April 5, 2013 | K130069 | INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| January 18, 2013 | K121762 | CARDIAC VX | LLZ | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 2, 2013 | K122457 | GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 2, 2012 | K121200 | FLIGHTPLAN FOR LIVER | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 13, 2012 | K121827 | GSI VIEWER WITH VUE OPTION | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| September 7, 2012 | K122164 | MR VESSELLQ XPRESS | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| June 18, 2012 | K120910 | CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| June 15, 2012 | K113456 | READY VIEW | LLZ | Substantially Equivalent | Ge Healthcare (Ge Medical Systems Scs) | accessdata.fda.gov |
| February 24, 2012 | K113408 | Q. FREEZE (MOTION VUE2) | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| February 14, 2012 | K113403 | GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM | OWB | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| December 22, 2011 | K110798 | SENOGRAPHE DS, SENOGRAPHE ESSENTIAL | MUE | Substantially Equivalent | General Electric Company | accessdata.fda.gov |
| December 13, 2011 | K113034 | GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM | IZI | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| October 6, 2011 | K103485 | SENOGRAPH DS, SENOGRAPH ESSENSTIAL | MUE | Substantially Equivalent | General Electric Company | accessdata.fda.gov |
| July 26, 2011 | K111209 | INTEGRATED INNOVA - S5I SYSTEM OPTION | IZI | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 26, 2011 | K110834 | AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 7, 2011 | K103480 | THORACIC VCAR | LLZ | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 2, 2009 | K092639 | INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| November 6, 2009 | K092954 | CADSTREAM VERSION 5 | LLZ | Substantially Equivalent | Confirma, Inc. | accessdata.fda.gov |
| October 30, 2009 | K093234 | INTEGRATED REGISTRATION | LLZ | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| August 25, 2009 | K092004 | GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| July 24, 2009 | K083421 | MR-TOUCH OPTION | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 29, 2009 | K091658 | GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 24, 2009 | K091673 | GE LIGHTSPEED ACT FP16 | JAK | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| September 25, 2008 | K081985 | AW SERVER | LLZ | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| May 9, 2008 | K081105 | GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) | JAK | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 26, 2008 | K073153 | CARDIQ FUNCTION XPRESS | JAK | Substantially Equivalent | GE Medical Systems SCS | accessdata.fda.gov |
| March 23, 2007 | K063324 | PET VCAR | JAK | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 26, 2006 | K061625 | AUTOBONE2 | JAK | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 23, 2006 | K061587 | FULLCARD ANALYSIS | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 7, 2006 | K061163 | INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT | OWB | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| May 30, 2006 | K061370 | CARDIQ FUSION | JAK | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 5, 2006 | K060779 | ADVANCE VESSEL ANALYSIS II | JAK | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 10, 2006 | K052839 | CT PERFUSION 4 | JAK | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 22, 2006 | K060259 | DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 | OWB | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 8, 2005 | K052995 | ADVANTAGE WORKSTATION 4.3. | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 16, 2005 | K052412 | INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 14, 2005 | K052345 | ADVANTAGE SIM MD | KPQ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 25, 2005 | K052157 | INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 11, 2005 | K050489 | INNOVA 2100 | OWB | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 18, 2004 | K042694 | ADVANCED LUNG ANALYSIS II | OEB | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| August 26, 2004 | K042053 | INNOVA 4100, INNOVA 3100 | OWB | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| June 22, 2004 | K041521 | VOLUME VIEWER PLUS | JAK | Substantially Equivalent | General Electric Medical Systems | accessdata.fda.gov |
| May 27, 2004 | K041270 | CT COLONOGRAPHY II | LLZ | Substantially Equivalent | General Electric Medical Systems | accessdata.fda.gov |
| April 19, 2004 | K040125 | SENOGRAPHIC STEREO | IZH | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| December 19, 2003 | K033867 | GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS | LNH | Substantially Equivalent | General Electric Co. | accessdata.fda.gov |
| December 4, 2003 | K033400 | SENO ADVANTAGE | LLZ | Substantially Equivalent | Ge Medical Systems W-400 | accessdata.fda.gov |
| October 30, 2003 | K032915 | ADVANTAGE 4D OPTION | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 16, 2003 | K033244 | DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION | OWB | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| August 22, 2003 | K031637 | INNOVA 3100 | OWB | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 26, 2014 | P130020 | SENOCLAIRE | OTE | 5 | November 21, 2025 | accessdata.fda.gov |
| January 28, 2000 | P990066 | GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | MUE | 36 | November 5, 2010 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 8, 2026 | 99042 | Class II | Ongoing | GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System | GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warni | accessdata.fda.gov |
| September 5, 2025 | 97657 | Class II | Ongoing | AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 | Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data. | accessdata.fda.gov |
| March 18, 2024 | 94305 | Class II | Ongoing | GE Healthcare Innova IGS 5, computed tomography x-ray system | GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly. | accessdata.fda.gov |
| December 26, 2023 | 93837 | Class II | Ongoing | Senographe Pristina | X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements. | accessdata.fda.gov |
| March 29, 2018 | 80177 | Class II | Terminated | Discovery IGS 730 Interventional Fluoroscopic X-ray Systems | The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. | accessdata.fda.gov |
Compare with other makers
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of System, X-Ray, Mammographic
- All makers of System, Image Processing, Radiological
- All makers of System, X-Ray, Tomography, Computed
- All makers of Generator, High-Voltage, X-Ray, Diagnostic
Updated July 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.