Atlas FDA

Ge Medical Systems, LLC

105 FDA 510(k) clearances · Manufacturer

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Enhanced Boundary for PCCT (K253560)Ge Medical Systems, LLC2026-06-24
Critical Care Suite with Enteric Tube Positioning AI Algorithm (K253502)Ge Medical Systems, LLC2026-04-14
Photonova Spectra, Photonova Spectra Select (K253520)Ge Medical Systems, LLC2026-03-20
SIGNA™ Bolt (K253780)Ge Medical Systems, LLC2026-02-06
SIGNA™ Sprint Select (K253779)Ge Medical Systems, LLC2026-02-05
AIR Recon DL (K252379)Ge Medical Systems, LLC2025-12-23
SIGNA™ Sprint (K251399)Ge Medical Systems, LLC2025-09-11
Revolution Vibe (K250941)Ge Medical Systems, LLC2025-08-01
Sonic DL (K243667)Ge Medical Systems, LLC2025-06-05
SIGNA Prime Elite (K250379)Ge Medical Systems, LLC2025-03-17
SIGNA MAGNUS (K241242)Ge Medical Systems, LLC2024-10-17
ECG-less Cardiac (K233750)Ge Medical Systems, LLC2024-04-02
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite (K223491)Ge Medical Systems, LLC2023-05-25
Auto Segmentation (K230082)Ge Medical Systems, LLC2023-05-04
Spectral Bone Marrow (K223514)Ge Medical Systems, LLC2023-03-09
Deep Learning Image Reconstruction (K213999)Ge Medical Systems, LLC2022-02-18
SIGNA PET/MR (K213709)Ge Medical Systems, LLC2022-01-20
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition (K213715)Ge Medical Systems, LLC2021-12-17
Critical Care Suite with Endotracheal Tube Positing AI algorithm (K211161)Ge Medical Systems, LLC2021-10-29
Discovery MI Gen2 (K211846)Ge Medical Systems, LLC2021-08-20
SIGNA 7.0T (K211118)Ge Medical Systems, LLC2021-05-13
AMX Navigate (K210982)Ge Medical Systems, LLC2021-04-28
MaxFOV 2 (K203617)Ge Medical Systems, LLC2021-03-02
Deep Learning Image Reconstruction for Gemstone Spectral Imaging (K201745)Ge Medical Systems, LLC2020-12-10
SIGNA 7.0T (K201615)Ge Medical Systems, LLC2020-10-15
Critical Care Suite (K183182)Ge Medical Systems, LLC2019-08-12
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition (K191777)Ge Medical Systems, LLC2019-07-26
Deep Learning Image Reconstruction (K183202)Ge Medical Systems, LLC2019-04-12
SnapShot Freeze 2 (K183161)Ge Medical Systems, LLC2019-02-13
SIGNA Premier (K183231)Ge Medical Systems, LLC2019-01-18
Optima XR240amx (K182234)Ge Medical Systems, LLC2018-09-06
PET Digital Gating (K180318)Ge Medical Systems, LLC2018-04-11
Optima XR240amx, AutoGrid (K173602)Ge Medical Systems, LLC2018-01-12
SIGNA Premier (K171128)Ge Medical Systems, LLC2017-07-14
HyperSense (K162722)Ge Medical Systems, LLC2017-04-20
Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist (K163331)Ge Medical Systems, LLC2017-03-17
SIGNA PET/MR (K163619)Ge Medical Systems, LLC2017-02-14
Revolution CT (K163213)Ge Medical Systems, LLC2016-12-16
HyperBand (K162403)Ge Medical Systems, LLC2016-11-18
Optima XR240amx (K162990)Ge Medical Systems, LLC2016-11-15
MAGiC (K161397)Ge Medical Systems, LLC2016-08-31
Discovery MI (K161574)Ge Medical Systems, LLC2016-08-11
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T (K160618)Ge Medical Systems, LLC2016-06-09
Low Dose CT Lung Cancer Screening Option for Qualified GE Systems (K151372)Ge Medical Systems, LLC2015-08-14
GenIQ (K143368)Ge Medical Systems, LLC2015-07-29
Customer Remote Console (CRC) (K150193)Ge Medical Systems, LLC2015-03-24
Discovery MR750 3.0T (K142361)Ge Medical Systems, LLC2014-12-05
SIGNA PET/MR (K142098)Ge Medical Systems, LLC2014-11-24
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T (K142085)Ge Medical Systems, LLC2014-09-26
Optima XR200amx, Optima XR220amx (K142383)Ge Medical Systems, LLC2014-09-25
CORTEX ID SUITE (K141074)Ge Medical Systems, LLC2014-09-18
DISCOVERY IQ (K141477)Ge Medical Systems, LLC2014-09-18
REVOLUTION CT (K133705)Ge Medical Systems, LLC2014-04-11
ASIR-V (K133640)Ge Medical Systems, LLC2014-03-25
DISCOVERY PET/CT 710 (K133657)Ge Medical Systems, LLC2014-03-21
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W (K132410)Ge Medical Systems, LLC2014-01-17
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (K132261)Ge Medical Systems, LLC2013-11-18
OPTIMA CT660 (K131576)Ge Medical Systems, LLC2013-08-30
DISCOVERY MR750W 3.0T (K130115)Ge Medical Systems, LLC2013-05-23
CARDIAC VX (K121762)Ge Medical Systems, LLC2013-01-18
MAVRIC SL (K113394)Ge Medical Systems, LLC2012-12-11
OPTIMA MR 430S (K123068)Ge Medical Systems, LLC2012-11-13
1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT (K121676)Ge Medical Systems, LLC2012-09-20
DISCOVERY CT750 HD (K120833)Ge Medical Systems, LLC2012-06-12
Q. FREEZE (MOTION VUE2) (K113408)Ge Medical Systems, LLC2012-02-24
OPTIMA MR450W (K113490)Ge Medical Systems, LLC2012-01-13
BRIVO XR385 (K103448)Ge Medical Systems, LLC2011-08-12
OPTIMA CT660 (K110227)Ge Medical Systems, LLC2011-07-20
OPTIMA XR120 (K111304)Ge Medical Systems, LLC2011-07-19
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX (K103476)Ge Medical Systems, LLC2011-06-16
DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS (K093581)Ge Medical Systems, LLC2011-04-19
1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL (K110610)Ge Medical Systems, LLC2011-04-01
THORACIC VCAR (K103480)Ge Medical Systems, LLC2011-03-07
1.5T OPTIMA MR430S (K103238)Ge Medical Systems, LLC2011-02-11
WIRELESS DR IMAGING OPTION-WDR1 (K102615)Ge Medical Systems, LLC2010-11-18
MR RADIATION ONCOLOGY OPTIONS (K102155)Ge Medical Systems, LLC2010-08-31
3D ASL (K092925)Ge Medical Systems, LLC2010-01-06
MR-TOUCH OPTION (K083421)Ge Medical Systems, LLC2009-07-24
OPTIMA MR450W (K091536)Ge Medical Systems, LLC2009-07-17
DISCOVERY MR450 (K083147)Ge Medical Systems, LLC2008-11-04
GE XTREME INJECTOR OPTION (K082960)Ge Medical Systems, LLC2008-10-17
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM (K082816)Ge Medical Systems, LLC2008-10-08
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM (K082761)Ge Medical Systems, LLC2008-10-08
AW SERVER (K081985)Ge Medical Systems, LLC2008-09-25
GE SIGNA MR ONCOLOGY PACKAGE (K081916)Ge Medical Systems, LLC2008-07-22
OPTIMA PET/CT 560 (K081496)Ge Medical Systems, LLC2008-06-12
SIGNA 3.0T MR750 SYSTEM (K081028)Ge Medical Systems, LLC2008-04-25
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER (K073167)Ge Medical Systems, LLC2008-01-04
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS (K072998)Ge Medical Systems, LLC2007-11-01
LIGHTSPEED 7.1 CT SCANNER SYSTEM (K061817)Ge Medical Systems, LLC2006-07-12
PRECISION THUNIS 800+ (K061028)Ge Medical Systems, LLC2006-06-07
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT (K061163)Ge Medical Systems, LLC2006-06-07
GE LIGHTSPEED XTRA CT SCANNER SYSTEM (K060052)Ge Medical Systems, LLC2006-04-19
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 (K060259)Ge Medical Systems, LLC2006-02-22
GE 1.5T SIGNA HDE MR SYSTEM (K052978)Ge Medical Systems, LLC2005-11-09
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (K052293)Ge Medical Systems, LLC2005-09-21
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ (K052157)Ge Medical Systems, LLC2005-08-25
INNOVA 2100 (K050489)Ge Medical Systems, LLC2005-03-11
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING (K042602)Ge Medical Systems, LLC2005-01-13
GE SIGNA PROFILE 6 INCH GP COIL (K041921)Ge Medical Systems, LLC2004-07-26
Next →

Track Ge Medical Systems, LLC automatically

Every clearance here is in the API, with alerts when new ones post.