GE Medical Systems SCS
Buc, FR
GE MEDICAL SYSTEMS SCS appears in FDA device records in Buc, FR. FDA records list 38 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 38 510(k) clearances for GE Medical Systems SCS between 2008 and 2026. The busiest year on record is 2020, with 5. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 2 |
| 2012 | 4 |
| 2013 | 1 |
| 2014 | 2 |
| 2016 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 5 |
| 2021 | 3 |
| 2022 | 4 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 4 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253770 | CardIQ Suite | JAK | Substantially Equivalent | |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | MUE | Substantially Equivalent | |
| K251199 | Allia Moveo | OWB | Substantially Equivalent | |
| K243672 | CardIQ Suite | JAK | Substantially Equivalent | |
| K243651 | VersaViewer | LLZ | Substantially Equivalent | |
| K243446 | 3DXR | OWB | Substantially Equivalent | |
| K233731 | CardIQ Suite | JAK | Substantially Equivalent | |
| K233714 | BreView | LLZ | Substantially Equivalent | |
| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | OWB | Substantially Equivalent | |
| K223424 | Spine Auto Views | JAK | Substantially Equivalent | |
| K223490 | FlightPlan for Embolization | LLZ | Substantially Equivalent | |
| K223152 | Vision 2, EVARVision, TrackVision 2, HeartVision 2 | LLZ | Substantially Equivalent | |
| K222895 | DynamicIQ | KPS | Substantially Equivalent | |
| K211180 | Liver Suite | JAK | Substantially Equivalent | |
| K213725 | CardIQ Suite | JAK | Substantially Equivalent | |
| K210807 | FlightPlan for Liver | LLZ | Substantially Equivalent | |
| K211247 | PET VCAR | KPS | Substantially Equivalent | |
| K200626 | VesselIQ Xpress | JAK | Substantially Equivalent | |
| K193306 | PROView | LLZ | Substantially Equivalent | |
| K193289 | FastStroke, CT Perfusion 4D | JAK | Substantially Equivalent | |
| K193281 | Hepatic VCAR | JAK | Substantially Equivalent | |
| K192277 | CardIQ Flow | KPS | Substantially Equivalent | |
| K193261 | FlightPlan for Embolization | LLZ | Substantially Equivalent | |
| K183204 | Bone VCAR (BVCAR) | JAK | Substantially Equivalent | |
| K183210 | Thoracic VCAR with GSI Pulmonary Perfusion | LLZ | Substantially Equivalent | |
| K180225 | GSI Viewer with GSI Fat Option | JAK | Substantially Equivalent | |
| K152584 | Stroke VCAR | JAK | Substantially Equivalent | |
| K152352 | Stereo 3D option for Vision Applications | LLZ | Substantially Equivalent | |
| K133278 | DISCOVERY IGS 740 | OWB | Substantially Equivalent | |
| K133649 | HEPATIC VCAR | JAK | Substantially Equivalent | |
| K131885 | SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) | MUE | Substantially Equivalent | |
| K121827 | GSI VIEWER WITH VUE OPTION | JAK | Substantially Equivalent | |
| K122164 | MR VESSELLQ XPRESS | LLZ | Substantially Equivalent | |
| K120910 | CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL | JAK | Substantially Equivalent | |
| K113403 | GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM | OWB | Substantially Equivalent | |
| K092639 | INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP | LLZ | Substantially Equivalent | |
| K093234 | INTEGRATED REGISTRATION | LLZ | Substantially Equivalent | |
| K073153 | CARDIQ FUNCTION XPRESS | JAK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9611343 | 1000284313 | GE MEDICAL SYSTEMS SCS | 283 RUE DE LA MINIERE, BUC 78530 FR | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ITYAssembly, Tube Housing, X-Ray, Diagnostic
- QIHAutomated Radiological Image Processing Software
- IWXBarrier, Control Panel, X-Ray, Movable
- OTEDigital Breast Tomosynthesis
- MUEFull Field Digital, System, X-Ray, Mammographic
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- OWBInterventional Fluoroscopic X-Ray System
- OEBLung Computed Tomography System, Computer-Aided Detection
- FMQRestraint, Protective
- LLZSystem, Image Processing, Radiological
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- KPQSystem, Simulation, Radiation Therapy
- KPSSystem, Tomography, Computed, Emission
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZHSystem, X-Ray, Mammographic
- JAKSystem, X-Ray, Tomography, Computed
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2553-2026 | 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 warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment. | Class II | Open, Classified | |
| Z-0068-2026 | 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. | Class II | Open, Classified | |
| Z-1783-2024 | GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems | 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. | Class II | Open, Classified | |
| Z-1782-2024 | GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems | 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. | Class II | Open, Classified | |
| Z-1781-2024 | GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems | 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. | Class II | Open, Classified | |
| Z-1780-2024 | GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems | 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. | Class II | Open, Classified | |
| Z-1779-2024 | GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems | 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. | Class II | Open, Classified | |
| Z-1778-2024 | GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems | 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. | Class II | Open, Classified | |
| Z-1777-2024 | 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. | Class II | Open, Classified | |
| Z-0862-2024 | Senographe Pristina | X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements. | Class II | Open, Classified | |
| Z-2388-2018 | Discovery IGS 740 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. | Class II | Terminated | |
| Z-2387-2018 | Innova IGS 630/520/530/540 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. | Class II | Terminated | |
| Z-2386-2018 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain