Ge Medical Systems, LLC
FDA 510(k) medical device clearances.
Top product codes for Ge Medical Systems, LLC
Recent clearances by Ge Medical Systems, LLC
1–100 of 105- K253560 — Enhanced Boundary for PCCT
- K253502 — Critical Care Suite with Enteric Tube Positioning AI Algorithm
- K253520 — Photonova Spectra, Photonova Spectra Select
- K253780 — SIGNA Bolt
- K253779 — SIGNA Sprint Select
- K252379 — AIR Recon DL
- K251399 — SIGNA Sprint
- K250941 — Revolution Vibe
- K243667 — Sonic DL
- K250379 — SIGNA Prime Elite
- K241242 — SIGNA MAGNUS
- K233750 — ECG-less Cardiac
- K223491 — Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
- K230082 — Auto Segmentation
- K223514 — Spectral Bone Marrow
- K213999 — Deep Learning Image Reconstruction
- K213709 — SIGNA PET/MR
- K213715 — 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
- K211161 — Critical Care Suite with Endotracheal Tube Positing AI algorithm
- K211846 — Discovery MI Gen2
- K211118 — SIGNA 7.0T
- K210982 — AMX Navigate
- K203617 — MaxFOV 2
- K201745 — Deep Learning Image Reconstruction for Gemstone Spectral Imaging
- K201615 — SIGNA 7.0T
- K183182 — Critical Care Suite
- K191777 — Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- K183202 — Deep Learning Image Reconstruction
- K183161 — SnapShot Freeze 2
- K183231 — SIGNA Premier
- K182234 — Optima XR240amx
- K180318 — PET Digital Gating
- K173602 — Optima XR240amx, AutoGrid
- K171128 — SIGNA Premier
- K162722 — HyperSense
- K163331 — Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist
- K163619 — SIGNA PET/MR
- K163213 — Revolution CT
- K162403 — HyperBand
- K162990 — Optima XR240amx
- K161397 — MAGiC
- K161574 — Discovery MI
- K160618 — Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
- K151372 — Low Dose CT Lung Cancer Screening Option for Qualified GE Systems
- K143368 — GenIQ
- K150193 — Customer Remote Console (CRC)
- K142361 — Discovery MR750 3.0T
- K142098 — SIGNA PET/MR
- K142085 — DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
- K142383 — Optima XR200amx, Optima XR220amx
- K141074 — CORTEX ID SUITE
- K141477 — DISCOVERY IQ
- K133705 — REVOLUTION CT
- K133640 — ASIR-V
- K133657 — DISCOVERY PET/CT 710
- K132410 — DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
- K132261 — DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
- K131576 — OPTIMA CT660
- K130115 — DISCOVERY MR750W 3.0T
- K121762 — CARDIAC VX
- K113394 — MAVRIC SL
- K123068 — OPTIMA MR 430S
- K121676 — 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
- K120833 — DISCOVERY CT750 HD
- K113408 — Q. FREEZE (MOTION VUE2)
- K113490 — OPTIMA MR450W
- K103448 — BRIVO XR385
- K110227 — OPTIMA CT660
- K111304 — OPTIMA XR120
- K103476 — BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
- K093581 — DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
- K110610 — 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
- K103480 — THORACIC VCAR
- K103238 — 1.5T OPTIMA MR430S
- K102615 — WIRELESS DR IMAGING OPTION-WDR1
- K102155 — MR RADIATION ONCOLOGY OPTIONS
- K092925 — 3D ASL
- K083421 — MR-TOUCH OPTION
- K091536 — OPTIMA MR450W
- K083147 — DISCOVERY MR450
- K082960 — GE XTREME INJECTOR OPTION
- K082761 — GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
- K082816 — GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
- K081985 — AW SERVER
- K081916 — GE SIGNA MR ONCOLOGY PACKAGE
- K081496 — OPTIMA PET/CT 560
- K081028 — SIGNA 3.0T MR750 SYSTEM
- K073167 — BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
- K072998 — IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
- K061817 — LIGHTSPEED 7.1 CT SCANNER SYSTEM
- K061028 — PRECISION THUNIS 800+
- K061163 — INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT
- K060052 — GE LIGHTSPEED XTRA CT SCANNER SYSTEM
- K060259 — DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
- K052978 — GE 1.5T SIGNA HDE MR SYSTEM
- K052293 — GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
- K052157 — INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ
- K050489 — INNOVA 2100
- K042602 — REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
- K041921 — GE SIGNA PROFILE 6 INCH GP COIL
Data sourced from openFDA. This site is unofficial and independent of the FDA.