FDA 510(k) Applications Submitted by GE MEDICAL SYSTEMS SCS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K073153 |
11/08/2007 |
CARDIQ FUNCTION XPRESS |
GE MEDICAL SYSTEMS SCS |
| K200626 |
03/10/2020 |
VesselIQ Xpress |
GE Medical Systems SCS |
| K211247 |
04/26/2021 |
PET VCAR |
GE Medical Systems SCS |
| K192277 |
08/22/2019 |
CardIQ Flow |
GE Medical Systems SCS |
| K193289 |
11/27/2019 |
FastStroke, CT Perfusion 4D |
GE Medical Systems SCS |
| K183204 |
11/19/2018 |
Bone VCAR (BVCAR) |
GE Medical Systems SCS |
| K243672 |
11/27/2024 |
CardIQ Suite |
GE Medical Systems SCS |
| K121827 |
06/21/2012 |
GSI VIEWER WITH VUE OPTION |
GE MEDICAL SYSTEMS SCS |
| K122164 |
07/20/2012 |
MR VESSELLQ XPRESS |
GE MEDICAL SYSTEMS SCS |
| K193306 |
11/29/2019 |
PROView |
GE Medical Systems SCS |
| K232344 |
08/04/2023 |
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR |
GE Medical Systems SCS |
| K133649 |
11/27/2013 |
HEPATIC VCAR |
GE MEDICAL SYSTEMS SCS |
| K233714 |
11/20/2023 |
BreView |
GE Medical Systems SCS |
| K193281 |
11/27/2019 |
Hepatic VCAR |
GE Medical Systems SCS |
| K133278 |
10/24/2013 |
DISCOVERY IGS 740 |
GE MEDICAL SYSTEMS SCS |
| K113403 |
11/17/2011 |
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM |
GE MEDICAL SYSTEMS SCS |
| K131885 |
06/25/2013 |
SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) |
GE MEDICAL SYSTEMS SCS |
| K092639 |
08/27/2009 |
INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP |
GE MEDICAL SYSTEMS SCS |
| K210807 |
03/17/2021 |
FlightPlan for Liver |
GE Medical Systems SCS |
| K223152 |
10/06/2022 |
Vision 2, EVARVision, TrackVision 2, HeartVision 2 |
GE Medical Systems SCS |
| K243446 |
11/06/2024 |
3DXR |
GE Medical Systems SCS |
| K223490 |
11/21/2022 |
FlightPlan for Embolization |
GE Medical Systems SCS |
| K193261 |
11/26/2019 |
FlightPlan for Embolization |
GE Medical Systems SCS |
| K180225 |
01/26/2018 |
GSI Viewer with GSI Fat Option |
GE Medical Systems SCS |
| K211180 |
04/20/2021 |
Liver Suite |
GE Medical Systems SCS |
| K152584 |
09/10/2015 |
Stroke VCAR |
GE MEDICAL SYSTEMS SCS |
| K183210 |
11/19/2018 |
Thoracic VCAR with GSI Pulmonary Perfusion |
GE Medical Systems SCS |
| K233731 |
11/21/2023 |
CardIQ Suite |
GE Medical Systems SCS |
| K243651 |
11/26/2024 |
VersaViewer |
GE Medical Systems SCS |
| K093234 |
10/15/2009 |
INTEGRATED REGISTRATION |
GE MEDICAL SYSTEMS SCS |
| K120910 |
03/26/2012 |
CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL |
GE MEDICAL SYSTEMS SCS |
| K222895 |
09/23/2022 |
DynamicIQ |
GE Medical Systems SCS |
| K223424 |
11/14/2022 |
Spine Auto Views |
GE Medical Systems SCS |
| K213725 |
11/26/2021 |
CardIQ Suite |
GE Medical Systems SCS |
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