Company ยท FR
GE Medical Systems SCS
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
38510(k) clearances (3 in 12 months)
13recalls (1 in 12 months)
13recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 21, 2026 | K253770 | CardIQ Suite GE Medical Systems SCS, FR | JAK |
| Mar 24, 2026 | K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright GE Medical Systems SCS, FR | MUE |
| Dec 9, 2025 | K251199 | Allia Moveo GE Medical Systems SCS, FR | OWB |
| Jun 18, 2025 | K243672 | CardIQ Suite GE Medical Systems SCS, FR | JAK |
| Apr 21, 2025 | K243651 | VersaViewer GE Medical Systems SCS, FR | LLZ |
| Feb 25, 2025 | K243446 | 3DXR GE Medical Systems SCS, FR | OWB |
| Aug 1, 2024 | K233731 | CardIQ Suite GE Medical Systems SCS, FR | JAK |
| Jan 25, 2024 | K233714 | BreView GE Medical Systems SCS, FR | LLZ |
| Oct 11, 2023 | K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR GE Medical Systems SCS, FR | OWB |
| Jul 13, 2023 | K223424 | Spine Auto Views GE Medical Systems SCS, FR | JAK |
| Mar 21, 2023 | K223490 | FlightPlan for Embolization GE Medical Systems SCS, FR | LLZ |
| Nov 22, 2022 | K223152 | Vision 2, EVARVision, TrackVision 2, HeartVision 2 GE Medical Systems SCS, FR | LLZ |
| Nov 22, 2022 | K222895 | DynamicIQ GE Medical Systems SCS, FR | KPS |
| May 2, 2022 | K211180 | Liver Suite GE Medical Systems SCS, FR | JAK |
| Mar 11, 2022 | K213725 | CardIQ Suite GE Medical Systems SCS, FR | JAK |
| Oct 22, 2021 | K210807 | FlightPlan for Liver GE Medical Systems SCS, FR | LLZ |
| Jul 27, 2021 | K211247 | PET VCAR GE Medical Systems SCS, FR | KPS |
| Feb 16, 2021 | K200626 | VesselIQ Xpress GE Medical Systems SCS, FR | JAK |
| Nov 17, 2020 | K193306 | PROView GE Medical Systems SCS | LLZ |
| Nov 12, 2020 | K193289 | FastStroke, CT Perfusion 4D GE Medical Systems SCS, FR | JAK |
| Mar 20, 2020 | K193281 | Hepatic VCAR GE Medical Systems SCS, FR | JAK |
| Feb 14, 2020 | K192277 | CardIQ Flow GE Medical Systems SCS, FR | KPS |
| Jan 24, 2020 | K193261 | FlightPlan for Embolization GE Medical Systems SCS, FR | LLZ |
| Apr 8, 2019 | K183204 | Bone VCAR (BVCAR) GE Medical Systems SCS, FR | JAK |
| Mar 29, 2019 | K183210 | Thoracic VCAR with GSI Pulmonary Perfusion GE Medical Systems SCS, FR | LLZ |
| Apr 24, 2018 | K180225 | GSI Viewer with GSI Fat Option GE Medical Systems SCS, FR | JAK |
| Jan 20, 2016 | K152584 | Stroke VCAR GE Medical Systems SCS, FR | JAK |
| Jan 20, 2016 | K152352 | Stereo 3D option for Vision Applications GE Medical Systems SCS, FR | LLZ |
| Apr 24, 2014 | K133278 | DISCOVERY IGS 740 GE Medical Systems SCS, FR | OWB |
| Apr 22, 2014 | K133649 | HEPATIC VCAR GE Medical Systems SCS | JAK |
| Sep 26, 2013 | K131885 | SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) GE Medical Systems SCS, FR | MUE |
| Sep 13, 2012 | K121827 | GSI VIEWER WITH VUE OPTION GE Medical Systems SCS | JAK |
| Sep 7, 2012 | K122164 | MR VESSELLQ XPRESS GE Medical Systems SCS | LLZ |
| Jun 18, 2012 | K120910 | CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL GE Medical Systems SCS, FR | JAK |
| Feb 14, 2012 | K113403 | GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM GE Medical Systems SCS, FR | OWB |
| Dec 2, 2009 | K092639 | INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP GE Medical Systems SCS | LLZ |
| Oct 30, 2009 | K093234 | INTEGRATED REGISTRATION GE Medical Systems SCS, FR | LLZ |
| Feb 26, 2008 | K073153 | CARDIQ FUNCTION XPRESS GE Medical Systems SCS, FR | JAK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | GE Medical Systems SCS GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System Open, Classified |
LLZ | K081985 |
| Oct 8, 2025 | GE Medical Systems, SCS AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 Open, Classified |
LLZ | K081985 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K181403 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K181403 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K232344 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K232344 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K232344 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems Open, Classified |
OWB | K181403 |
| May 6, 2024 | GE Medical Systems, SCS GE Healthcare Innova IGS 5, computed tomography x-ray system Open, Classified |
OWB | K181403 |
| Feb 8, 2024 | GE Medical Systems, SCS Senographe Pristina Open, Classified |
MUE | K162268 K173576 +3 |
| Oct 5, 2018 | GE Medical Systems, SCS Discovery IGS 740 Interventional Fluoroscopic X-ray Systems Terminated |
OWB | K133278 |
| Oct 5, 2018 | GE Medical Systems, SCS Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems Terminated |
OWB | K111209 K122457 |
| Oct 5, 2018 | GE Medical Systems, SCS Discovery IGS 730 Interventional Fluoroscopic X-ray Systems Terminated |
OWB | K113403 K122457 |