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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2017-04-13 |
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2020-05-26 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2020-05-26 |
| Table, Radiologic | KXJ | Class 2 | Radiology | No | 1998-08-17 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2010-06-23 |
| Synchronizer, Ecg / Respirator, Radiographic | IXO | Class 1 | Radiology | No | 2019-08-29 |
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | OUO | Class 2 | Radiology | No | 2014-12-02 |
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