Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611343

FEI Number

1000284313

Entity Name

GE MEDICAL SYSTEMS SCS

City/State/Country

BUC, FR

Establishment Address

283 RUE DE LA MINIERE, BUC 78530, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091673

PMA Number

N/A

All Registered Proprietary Names

Hepatic VCAR Hepatic VCAR Gen2 Advantage 4D Innova 4100-IQ Innova 3100-IQ Innova 2121-IQ Innova 3131-IQ Innova 2100-IQ INNOVA IGS 620 Optima CL323i Integrated Innova - s5i system option INNOVA IGS 530 INNOVA IGS 630 Optima CL320i INNOVA IGS 520 INNOVA IGS 540 Thoracic VCAR GSI PP GSI Pulmonary Perfusion TVCAR Radiation Screen Radiation Screen Extension Radiation Screen for Control Station Liver Suite PET VCAR DEAUVILLE PET VCAR cvi42 cvi42_Mitral cvi42_cmr42 SnapShot Freeze SnapShot Freeze 2 SSF2 SSF Innova 3100 Seno Iris FlightPlan for Liver with Parenchyma Analysis option FlightPlan for EVAR MR VesselIQ Xpress MR Touch MR-Touch Option Innova 4100 Innova 2100 IQ Discovery IGS 740 Discovery IGS 7 3DXR Discovery IGS 7 OR CardiacVX CardiacVX Flow CardiacVX StarMap Stereo 3D Stereo 3D option for Vision Applications AdvantageALA Lung VCAR Senographe Pristina Pristina Via EVARVision TrackVision 2 Vision 2 HeartVision 2 CT Perfusion 4D Neuro CT Perfusion 4D Multi-Organ Send by mail FastStroke Dynamic CT Myocardial Perfusion CT Perfusion 4D CT Perfusion 4D Neuro Gen2 CardIQ Xpress Process CardIQ Xpress Reveal CardIQ Xpress 2 CardIQ Xpress Process 2 with Snapshot Freeze option CardIQ Fusion PET CardIQ Fusion SPECT AdvantageSim¿ MD GenIQ Senographe Essential Stereotaxy Senographe DS Stereotaxy Stereotix Senographic Stereo FlightPlan for Liver Dentascan MR Pasting MR pasting 1.1 Innova 2121 IQ Innova 3131 IQ Innova 3100-IQ Innova 4100-IQ Innova 2100-IQ Sample Imaging for Senographe Pristina SmartScore Smartscore 4 Dynamic Shuttle AutoBone Refresh AutoBone Xpress SenoBright HD Pristina Serena Bright Innova EPVision 2 Senographe 600T Senographe 500T CT Perfusion MULTI-ORGAN CT Perfusion 4D Multi-Organ CT Perfusion 4 Neuro CT Perfusion 4D Neuro Dynamic CT Myocardial Perfusion CT Perfusion 4D DMR+ Senographe DMR Mirada RTx AngioCard ReportCard 4 StarMap GE Delta Software Option for MRI Flow Analysis Innova 3100 Innova 4100 Performix Plus LU43318ST LU8548STR Performix 40 Plus MAXIRAY 100 TH-M1 APOLLON Solarix 350 Brightspeed Performix HD 43318 45645 Performix Pulsar Performix VCT Plus Performix 40 LU45649ST LU45645STR Vamana Surgery MX100 FL MX135CT TH1.1 Maxiray MX100 FL Maxiray CT VCT MX200CT/Performix Ultra 5855555 LU45645 SB-80-200R Performix 160A LU8743STR Ergo MONOBLOCK Performix Pro VCT 100 LU45649 Maxiray MX100 RAD LU45649STR LU45645ST LU40782 Brivo OEC 2.2A X-ray Generator MX100 RAD LU8743ST Vamana RAD LU8548ST 40782 Performix HD Plus Artemis MX165 NP Quantix 160 Maxiray CT Ultra Performix HDw VersaViewer DynamicIQ cmr42 cvi42_cmr42 TAVI Analysis TAVI VesselIQ Xpress FlightPlan for EVAR TAVI Analysis Gen2 AVA Xpress TAVI Analysis VessellQ IXray Optima CT680 Expert Revolution Maxima Revolution Ace Console Generation Upgrade Senographe Pristina (Pristina Via) Pristina Serena Pristina Serena Bright SenoBright HD Motion VUE Q.Freeze 2 Q.Freeze Pristina Serena 3D CardIQ Flow Stereotix eContrast NEW Innova CT Pristina Serena TAVI Analysis FlightPlan for EVAR VesselIQ Xpress CortexID Suite SenoVision Advantage Paste Innova 2100-IQ Innova 3100-IQ Innova 4100-IQ Patient-Assisted Compression Self-Compression Pristina Dueta INNOVA IGS 620 INNOVA 2121-IQ INNOVA 3131-IQ DISCOVERY IGS 730 INNOVA 4100-IQ INNOVA 2100-IQ Optima IGS 320 Optima CL323i Optima CL320i INNOVA 3100-IQ INNOVA IGS 630 Optima IGS 330 Innova IGS 5 3DXR Discovery IGS 7 OR Discovery IGS 7 Innova IGS 6 INNOVA IGS 540 INNOVA IGS 530 INNOVA IGS 520 Allia Moveo Spine Auto Views INNOVA 4100-IQ Mobile Senographe Essential Senographe Care Senographe Essential Senographe DS Senographe 2000D PET VCAR Allia IGS 3 Allia IGS 7 OR Allia IGS 7 Allia IGS 5 Bone VCAR BVCAR MAGiC MAGnetic resonance image Compilation Innova 2121 IQ Innova 3100 Innova 4100 Innova 3131 IQ Innova 3100-IQ Innova 2100-IQ Innova 4100-IQ Innova 2121-IQ Innova 3131-IQ FlightPlan for Embolization, with AI Segmentation option FlightPlan for Embolization AdvantageCTC Pro3D Advantage CTC Plus AdvantageCTC Pro3D EC AdvantageCTC Pro FastStroke CardIQ Suite AW Remote Access AW 4.4 AW Volume Share 2 AW 4.3 AW Volume Share 4 advantage workstation 4.3 AW 4.5 SenoBright - CESM TVCAR Thoracic VCAR Jedi TTH Jedi80RF1T Jedi80R1T Jedi 80 RD 1T Jedi42CT Jedi 50 Plus R1T ZEUS Zyx Jedi 80 RF 1T Jedi50R1T JEDI 80 RF1T Jedi 50 R 1T Jedi NP+V1.5 TTH MAESTRO TTH HAWKEYE DMR JEDI 60 DC Jedi 60 DC Djinn Mammo Jedi80RF2T Prisme Jedi 42 CT JEDI SC FAST kV DJINN BEETLE VMX MPPU JEDI HP JEDI 100 VASC 1T CT MINI Jedi60CT X-Ray Generator ZJ/QJ Prodigy/DPX Series High Voltage Power Supply Jedi 60 DC LITE SYJ MPG50 JEDI 60 DC LITE Jedi 60DC Lite MPG100 VAMP Jedi 80 RF 2T JEDI VCT Jedi 80 R 1T TTH 8800 ZEUS, ZJ/QJ Jedi 100 VASC 1 BONZAI Djinn Beetle Jedi 60 CT Jedi 60DC GAIA INTERVENTIONAL GENERATOR Djinn Tonix CardEP INTERACT Discovery RT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-03-30
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-03-30
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-23
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2011-08-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-04-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-04-23
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	Class 1	892.6500	2022-10-31
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-07-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-07-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-03-11
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2021-08-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-08-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-12-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-03-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-03-29
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2011-06-15
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2011-06-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-08-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-10-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-11-07
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2012-11-07
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2010-07-15
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2010-06-21
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2010-06-21
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2012-01-03
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2012-01-03
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2014-06-02
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2014-06-02
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-06-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-01-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2016-02-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-02-29
OEB	Lung Computed Tomography System, Computer-Aided Detection	Radiology	Class 2	892.2050	2009-12-03
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2016-11-07
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-11-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-11-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-11-13
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-11-13
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2012-08-07
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-23
KPQ	System, Simulation, Radiation Therapy	Radiology	Class 2	892.5840	2010-06-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-08-24
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2011-04-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-01-08
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-23
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2012-02-15
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2011-03-14
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2011-03-14
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2011-03-14
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2019-08-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-23
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2021-07-12
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2020-05-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-04-09
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2012-01-25
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-23
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2007-11-05
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-03-29
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2010-06-23
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2007-11-05
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2007-11-05
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	1999-10-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-04-22
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2022-11-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-11-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-10-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-03-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-03-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-10-28
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2026-04-08
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2012-03-19
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2019-04-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-02-17
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2020-02-17
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2011-12-16
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2022-10-31
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-22
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2018-05-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-23
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2014-11-13
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2012-01-25
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2010-06-23
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2010-06-21
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2010-06-21
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2010-06-21
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2017-09-06
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2013-02-11
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2013-02-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2013-02-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-12-10
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-12-10
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-12-10
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2025-12-10
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-08-09
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-08-09
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2010-06-21
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2010-06-21
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2006-02-07
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2010-06-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-23
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2023-10-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2023-10-24
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2023-10-24
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2023-10-24
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-04-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-04-23
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2017-01-04
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2011-03-14
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2011-03-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2011-03-14
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2010-06-21
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2010-06-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-08-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2010-06-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-02-01
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-03-29
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-03-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2005-12-22
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2012-01-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-03-29
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2004-09-24
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-23
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2012-02-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2012-02-14

Official Correspondent

No official correspondent registered.

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3017991646	CARDIOWISE, INC.	Fayetteville, AR, US
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3036758981	TAEYOUNG SOFT	Gwacheon-si Gyeonggi, KR
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611343. Last updated year: 2026. Please use registration number 9611343 when referencing this establishment in official correspondence.