FDA 510(k) Applications Submitted by GE MEDICAL SYSTEMS, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K073167 |
11/09/2007 |
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER |
GE MEDICAL SYSTEMS, LLC |
| K213709 |
11/24/2021 |
SIGNA PET/MR |
GE Medical Systems, LLC |
| K211118 |
04/15/2021 |
SIGNA 7.0T |
GE Medical Systems, LLC |
| K201615 |
06/15/2020 |
SIGNA 7.0T |
GE Medical Systems, LLC |
| K183231 |
11/20/2018 |
SIGNA Premier |
GE Medical Systems, LLC |
| K211161 |
04/19/2021 |
Critical Care Suite with Endotracheal Tube Positing AI algorithm |
GE Medical Systems, LLC |
| K182234 |
08/17/2018 |
Optima XR240amx |
GE Medical Systems, LLC |
| K142383 |
08/26/2014 |
Optima XR200amx, Optima XR220amx |
GE Medical Systems, LLC |
| K162990 |
10/27/2016 |
Optima XR240amx |
GE Medical Systems, LLC |
| K173602 |
11/21/2017 |
Optima XR240amx, AutoGrid |
GE Medical Systems, LLC |
| K223491 |
11/21/2022 |
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite |
GE Medical Systems, LLC |
| K081916 |
07/07/2008 |
GE SIGNA MR ONCOLOGY PACKAGE |
GE MEDICAL SYSTEMS, LLC |
| K083421 |
11/19/2008 |
MR-TOUCH OPTION |
GE MEDICAL SYSTEMS, LLC |
| K141074 |
04/25/2014 |
CORTEX ID SUITE |
GE MEDICAL SYSTEMS, LLC |
| K081496 |
05/29/2008 |
OPTIMA PET/CT 560 |
GE MEDICAL SYSTEMS, LLC |
| K113408 |
11/18/2011 |
Q. FREEZE (MOTION VUE2) |
GE MEDICAL SYSTEMS, LLC |
| K133657 |
11/27/2013 |
DISCOVERY PET/CT 710 |
GE MEDICAL SYSTEMS, LLC |
| K162722 |
09/29/2016 |
HyperSense |
GE MEDICAL SYSTEMS, LLC |
| K060052 |
01/06/2006 |
GE LIGHTSPEED XTRA CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
| K131576 |
05/31/2013 |
OPTIMA CT660 |
GE MEDICAL SYSTEMS, LLC |
| K132410 |
08/02/2013 |
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W |
GE MEDICAL SYSTEMS, LLC |
| K133705 |
12/03/2013 |
REVOLUTION CT |
GE MEDICAL SYSTEMS, LLC |
| K141477 |
06/04/2014 |
DISCOVERY IQ |
GE MEDICAL SYSTEMS, LLC |
| K133640 |
11/27/2013 |
ASIR-V |
GE MEDICAL SYSTEMS, LLC |
| K163619 |
12/22/2016 |
SIGNA PET/MR |
GE Medical Systems, LLC |
| K160618 |
03/03/2016 |
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T |
GE MEDICAL SYSTEMS, LLC |
| K162403 |
08/29/2016 |
HyperBand |
GE Medical Systems, LLC |
| K142085 |
07/31/2014 |
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T |
GE MEDICAL SYSTEMS, LLC |
| K142361 |
08/25/2014 |
Discovery MR750 3.0T |
GE MEDICAL SYSTEMS, LLC |
| K120833 |
03/19/2012 |
DISCOVERY CT750 HD |
GE MEDICAL SYSTEMS, LLC |
| K151372 |
05/21/2015 |
Low Dose CT Lung Cancer Screening Option for Qualified GE Systems |
GE Medical Systems, LLC |
| K132261 |
07/19/2013 |
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) |
GE MEDICAL SYSTEMS, LLC |
| K102615 |
09/09/2010 |
WIRELESS DR IMAGING OPTION-WDR1 |
GE MEDICAL SYSTEMS, LLC |
| K103448 |
11/24/2010 |
BRIVO XR385 |
GE MEDICAL SYSTEMS, LLC |
| K040372 |
02/17/2004 |
LIGHTSPEED 7.0 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
| K033502 |
11/05/2003 |
LIGHTSPEED 6.0 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
| K150193 |
01/28/2015 |
Customer Remote Console (CRC) |
GE MEDICAL SYSTEMS, LLC |
| K201745 |
06/26/2020 |
Deep Learning Image Reconstruction for Gemstone Spectral Imaging |
GE Medical Systems, LLC |
| K223514 |
11/22/2022 |
Spectral Bone Marrow |
GE Medical Systems, LLC |
| K061028 |
04/13/2006 |
PRECISION THUNIS 800+ |
GE MEDICAL SYSTEMS, LLC |
| K060259 |
02/01/2006 |
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 |
GE MEDICAL SYSTEMS, LLC |
| K050489 |
02/25/2005 |
INNOVA 2100 |
GE MEDICAL SYSTEMS, LLC |
| K061163 |
04/26/2006 |
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT |
GE MEDICAL SYSTEMS, LLC |
| K041921 |
07/16/2004 |
GE SIGNA PROFILE 6 INCH GP COIL |
GE MEDICAL SYSTEMS, LLC |
| K052157 |
08/08/2005 |
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ |
GE MEDICAL SYSTEMS, LLC |
| K032795 |
09/08/2003 |
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM |
GE MEDICAL SYSTEMS, LLC |
| K032915 |
09/22/2003 |
ADVANTAGE 4D OPTION |
GE MEDICAL SYSTEMS, LLC |
| K052978 |
10/24/2005 |
GE 1.5T SIGNA HDE MR SYSTEM |
GE MEDICAL SYSTEMS, LLC |
| K041476 |
06/03/2004 |
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM |
GE MEDICAL SYSTEMS, LLC |
| K052293 |
08/23/2005 |
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM |
GE MEDICAL SYSTEMS, LLC |
| K191777 |
07/02/2019 |
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition |
GE Medical Systems, LLC |
| K180318 |
02/05/2018 |
PET Digital Gating |
GE Medical Systems, LLC |
| K061817 |
06/28/2006 |
LIGHTSPEED 7.1 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
| K081028 |
04/11/2008 |
SIGNA 3.0T MR750 SYSTEM |
GE MEDICAL SYSTEMS, LLC |
| K091536 |
05/26/2009 |
OPTIMA MR450W |
GE MEDICAL SYSTEMS, LLC |
| K042602 |
09/24/2004 |
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING |
GE MEDICAL SYSTEMS, LLC |
| K072998 |
10/24/2007 |
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS |
GE MEDICAL SYSTEMS, LLC |
| K210982 |
04/01/2021 |
AMX Navigate |
GE Medical Systems, LLC |
| K171128 |
04/17/2017 |
SIGNA Premier |
GE Medical Systems, LLC |
| K161397 |
05/19/2016 |
MAGiC |
GE Medical Systems, LLC |
| K163331 |
11/28/2016 |
Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist |
GE Medical Systems, LLC |
| K130115 |
01/16/2013 |
DISCOVERY MR750W 3.0T |
GE MEDICAL SYSTEMS, LLC |
| K121762 |
06/15/2012 |
CARDIAC VX |
GE MEDICAL SYSTEMS, LLC |
| K110610 |
03/03/2011 |
1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL |
GE MEDICAL SYSTEMS, LLC |
| K111304 |
05/09/2011 |
OPTIMA XR120 |
GE MEDICAL SYSTEMS, LLC |
| K103476 |
11/24/2010 |
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX |
GE MEDICAL SYSTEMS, LLC |
| K230082 |
01/11/2023 |
Auto Segmentation |
GE Medical Systems, LLC |
| K103238 |
11/02/2010 |
1.5T OPTIMA MR430S |
GE MEDICAL SYSTEMS, LLC |
| K142098 |
08/01/2014 |
SIGNA PET/MR |
GE MEDICAL SYSTEMS, LLC |
| K113490 |
11/23/2011 |
OPTIMA MR450W |
GE MEDICAL SYSTEMS, LLC |
| K121676 |
06/07/2012 |
1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT |
GE MEDICAL SYSTEMS, LLC |
| K081985 |
07/14/2008 |
AW SERVER |
GE MEDICAL SYSTEMS, LLC |
| K103480 |
11/26/2010 |
THORACIC VCAR |
GE MEDICAL SYSTEMS, LLC |
| K082816 |
09/25/2008 |
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
| K082960 |
10/03/2008 |
GE XTREME INJECTOR OPTION |
GE MEDICAL SYSTEMS, LLC |
| K102155 |
07/30/2010 |
MR RADIATION ONCOLOGY OPTIONS |
GE MEDICAL SYSTEMS, LLC |
| K110227 |
01/25/2011 |
OPTIMA CT660 |
GE MEDICAL SYSTEMS, LLC |
| K082761 |
09/22/2008 |
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
| K093581 |
11/18/2009 |
DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS |
GE MEDICAL SYSTEMS, LLC |
| K092925 |
09/23/2009 |
3D ASL |
GE MEDICAL SYSTEMS, LLC |
| K123068 |
10/01/2012 |
OPTIMA MR 430S |
GE MEDICAL SYSTEMS, LLC |
| K083147 |
10/24/2008 |
DISCOVERY MR450 |
GE MEDICAL SYSTEMS, LLC |
| K113394 |
11/16/2011 |
MAVRIC SL |
GE MEDICAL SYSTEMS, LLC |
|
|
