FDA Registration Active 🇺🇸 United States

GE MEDICAL SYSTEMS, LLC

Reg #: 2183553 · FEI: 2183553 · Expires 2026
Products
7
Proprietary Names
153
Establishment Types
2
Classifications
7

Registration Details

Registration Name
GE MEDICAL SYSTEMS, LLC
Registration Number
2183553
FEI Number
2183553
Status
Active
Expiry Year
2026
Initial Importer
No
Address
3200 N GRANDVIEW BLVD
City
WAUKESHA
State
WI
ZIP
53188
Country
US

Regulatory Submissions

510(k) Number
K163331

Owner / Operator

Firm Name
GE HealthCare Technologies Inc.
Operator Number
9912004
Address
3000 N. Grandview Blvd
City
Waukesha
State
WI
Postal Code
53188
Country
US

Products

Device Name Product Code
System, Nuclear Magnetic Resonance Imaging LNH
Coil, Magnetic Resonance, Specialty MOS
System, Nuclear Magnetic Resonance Spectroscopic LNI
Table, Radiologic KXJ
System, Image Processing, Radiological LLZ
Synchronizer, Ecg / Respirator, Radiographic IXO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance OUO

Proprietary Names

Optima MR450w 1.5T Discovery MR450 1.5T Discovery MR750 3T SIGNA Artist Discovery MR750w 3T SIGNA Architect Optima MR450w GEM XP Gradient Optima MR450w GEM Optima MR450w 1T MSK Extreme SIGNA Premier AIR Recon DL Optima MR430s 1.5T Optima MR430s Optima MR430s MRI Scanner GE Signa MR Oncology Package Quadrature QD Body Flex Coil 3T AA TDI POSTERIOR ARRAY TDI HEAD NECK ARRAY SIGNA Pioneer GE SIGNA EXCITE MR SURGICAL OPTION SIGNA Bolt 3T AIR PA XL GP Flex Coil 1T. GP Flex Coil 1.5T 1.5T INFINITY TWINSPEED MR SYSTEM MR TWINSPEED SYSTEM DISCOVERY MR 450-1.5T SPLIT HEAD COIL Discovery MR450 DISCOVERY MR 750- 3T SPLIT HEAD COIL Discovery MR750 System Signa Horizon Cx Signa MR/I Signa Infinity Signa Horizon Lx EchoSpeed Plus SmartSpeed HighSpeed Plus AngioCard ReportCard 4 StarMap GE Delta Software Option for MRI Flow Analysis 3T SIGNA VH/I (T/R) BODY IMAGING COIL Signa 3T Infinity with EXCITE Signa Excite 3T GE 3T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM 3T SIGNA HDxt Mobile 3T SPLIT HEAD COIL 1.5T SPLIT HEAD COIL SIGNA VIBRANT 3T SIGNA HDXt 1.5T SIGNA HDXt 1.5T Signa HDxt Mobile 3T GE 6-Channel Phased Array Flex Coil 1.5T GE 6-Channel Phased Array Flex Coil MAGiC MAGnetic resonance image Compilation GE SIGNA EXCITE 3T 6 CHANNEL PHASED ARRAY FLEX COIL GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL BrainWave Adv Visualization BrainWave Performance Brainwave PA Performance Brainwave PA Fusion Performance BrainWave Adv DTI Tracking BrainWave Fusion Perf BrainWave Struct Reporting BrainWave Post Acquisition (PA) BrainWave BrainWave Tract Generation Brainwave PA BrainWave Skull Stripping Brainwave Resting State 3D ASL GE SIGNA 3T WITH EXCITE MR SYSTEM 3T Detachable Table 3T eXpress Table 1.5T eXpress Table 1.5T Detachable Table IDEAL IQ FuncTool Upgrade FuncTool eDWI Functool CSI Functool FiberTrack Functool Performance Functool Fusion eDWI Functool MR Touch Functool 3DASL MR Touch MR-Touch Option MR High Impedance ECG Cable SIGNA 7T FuncTool BrainStat BrainStat 1.5T MSK Extreme GE 3T General Purpose Flex Coil Signa HDi 1.5T GE 3T Signa HDxt MR System Signa HDi GE 1.5T Signa HDx MR System GE 1.5T Signa HDxt MR System GE 3T Signa HDx MR System Signa Vibrant Discovery MR750W MR 750W 3T GEM PA (Aurora only) 3T GEM HNU (Aurora only) 3T GEM PVA (Aurora only) 3T GEM Anterior Array (Aurora only) 1.5T Split Head Coil Optima MR 450w GEM Optima MR 450w MAVRIC SL 3T GE Signa Excite HD MR System 1.5T GE Signa Excite HD MR System 1.5T Signa HD HyperSense SIGNA Hero Cardiac Array 1.5T CARDIAC PHASED ARRAY COIL 4-Ch Cardiac Array Sonic DL 3T HNU 3T LAA 3T PET/MR CMA 3T UAA SIGNA PET/MR IDEAL HyperBand 1.5T GEM PA 1.5T GEM Anterior Array 1.5T GEM HNU 1.5T GEM PVA GEM Option for 1.5T MRI Systems CardiacVX CardiacVX Flow CardiacVX StarMap EXAM (PROSE) SOFTWARE OPTION FOR MR PROSTATE SPECTROSCOPY AND IMAGING Functool DTI Optima MR430s 1.5T MR Scanner MR Radiation Oncology Options Torso Array 1T Torso Array 1.5T 4Ch Torso Array MR Pasting MR pasting 1.1 Signa Excite 1.5T Expert. SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 5" ROUND COIL 1.5T 3" ROUND COIL 1.5T

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device