FDA Registration
Active
🇺🇸 United States
GE Healthcare Coils
Reg #: 1529041
·
FEI: 3005214683
·
Expires 2026
Products
6
Proprietary Names
193
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- GE Healthcare Coils
- Registration Number
- 1529041
- FEI Number
- 3005214683
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1515 DANNER DR
- City
- AURORA
- State
- OH
- ZIP
- 44202
- Country
- US
Regulatory Submissions
- 510(k) Number
- K031366
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 |
|---|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2010-07-16 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2016-02-22 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2011-11-03 |
| Test-Pattern, Radiographic | IXF | Class 1 | Radiology | No | 2003-10-07 |
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | OUO | Class 2 | Radiology | No | 2014-12-02 |
| Cradle, Patient, Radiologic | KXH | Class 1 | Radiology | No | 2012-11-26 |
Proprietary Names
premier 9000 8 channel phased array
1.5T, 8Ch CTL coil-HDx
CTL
8 Channel CTL Coil
Signa HD 1.5T 8-Ch CTL Coil
1.5T HD 8 CH CTL Coil
1.5T 8 CH CTL Coil
magna 5000 phased array CTL Spine
Coil
3T AA
TDI POSTERIOR ARRAY
TDI HEAD NECK ARRAY
SIGNA Pioneer
1.5T GEM RT Open Array
1.5T SPLIT HEAD COIL
3T SPLIT HEAD COIL
3T GE Signa Excite HD MR System
1.5T GE Signa Excite HD MR System
1.5T Signa HD
Discovery MR750w 3T
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)
11000 rapture phased array peripheral VASCULAR COIL
1.5T 16-Ch Peripheral Vascular Coil
1.5T HD Lower Leg
3T HD Breast Array
3T 8Ch GEM Breast Coil
3T HD FLAT GEM Table Breast Array
1.5T 8Ch GEM Breast Coil
liberty 9000 8-ch breast coil with disposable biopsy plate
1.5T HD Breast Array
Lateral Large Grid Biopsy Plate
Medial Large Grid Breast Biopsy Plate
1.5T HD Flat GEM Table Breast Array
Spine Coil.
Magna 5000 Phased Array CTL
CTL ARRAY COIL.
1.5T 4CH Large Flex Coil
1.5T 4CH Small Flex Coil
3T 16ch AIR AA
3T 16 Channel Head Neck Spine Coil
48Ch Head Coil
GP Flex Coil 1T.
GP Flex Coil 1.5T
3T AIR MP M
3T AIR MP L
3T AIR MP Large
3T AIR MP Medium
GE 1.5T SIGNA HDE MR SYSTEM
AIR Anterior Array
AIR Posterior Array
Torso Array 1T
Torso Array 1.5T
4Ch Torso Array
neurovascular coil
millennium 9000 phased array
prima iii totalsense torso coil
EXCITE 3T 8 CHANNEL TORSO ARRAY
3T HDMR2 8Ch HD Torso Coil
mark 9000 phased array shoulder coil
1.5T HD Shoulder Array
Signa HD 1.5T Phased Array Shoulder 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
disposable biopsy plate
liberty 9000 breast coil with
OPENBODY COIL
Interventional Body Coil
phased array knee and foot coil
8 Channel Cardiac Phased Array Coil
1.5T HD 8Ch Cardiac Array
Cardiac Array 1.5T
CARDIAC PHASED ARRAY COIL
4-Ch Cardiac Array
1.5T TDI Posterior Array
1.5T Anterior Array
1.5T TDI Head Neck Array
Signa Voyager Premier Edition
SIGNA Voyager Quantum
SIGNA Voyager
SIGNA Bolt
3T AIR PA XL
3T TORSO PHASED ARRAY COIL
3T SIGNA HDxt Mobile
SIGNA VIBRANT
3T SIGNA HDXt
1.5T SIGNA HDXt
1.5T Signa HDxt Mobile
millennium 5000 neurovascular coil
9E Express AA coil
16CH Express HNA coil
8ch Express PA coil
1.5T EXPRESS COIL - 16E HEAD NECK ARRAY
1.5T EXPRESS COIL - 9E ANTERIOR ARRAY
3T 8CH CTL ARRAY
3t 8-channel cervical-thoracic-lumbar
3T HD CTL ARRAY
Coil QA Phantom
Knee/Foot Phantoms
Knee Coil Phantom
Image Slice Phantom
T/L Phantom
Foot SNR Phantom
CT Phantom
Headset
PHANTOM
48CH Head Coil
Discovery 3T 32 CH Body Array Coil (Posterior)
Discovery 3T 32 CH Body Array Coil (Anterior)
GE 1.5T 8 CHANNEL TORSO COIL
Signa HD 1.5T 8-CH Body Array Coil
8ch Express Suite
Optima MR360
Brivo MR355
EXPRESS COIL - HEAD NECK ARRAY
EXPRESS COIL - ANTERIOR ARRAY
EXPRESS COIL - POSTERIOR ARRAY
1.5T GEM PA
1.5T GEM Anterior Array
1.5T GEM HNU
1.5T GEM PVA
GEM Option for 1.5T MRI Systems
coil
mark 5000 phased array shoulder
millennium iii 3t-8-channel neurovascular
8-Ch NV Array
3T Excite III 8 Channel HD Neurovascular Coil
HD Neurovascular Array
3T HD Neurovascular Array
1.5T, 4 CH. CTL SPINE COIL,
Premier 7000 CTL Spine coil
Signa HD 1.5T CTL Spine Coil
PHASED ARRAY-HDe
1.5T 4 Ch. Premier 7000 CTL Coil
Signa HDe 1.5T 4CH CTL Spine Coil
premier iii phased array ctl spine
3T 8CH CTL
3T 8-Channel CTL Phase II
Discovery MR750 3T
DISCOVERY MR 750- 3T SPLIT HEAD COIL
Discovery MR750 System
spirit iii totalsense cardiac coil
3T HD 8ch Cardiac Array
1.5T Head, Neck, Spine Array
1.5t 16 channel brain-spine array coil;
HD HEAD NECK AND SPINE ARRAY
cervico-thoracic-lumbar (CTL) array
3t 4-channel
SIGNA Sprint
1.5T AIR Posterior Array
GE 3T General Purpose Flex Coil
Signa Excite 1.5T Expert.
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
5" ROUND COIL 1.5T
3" ROUND COIL 1.5T
3T GEM RT Open Array
mark iii phased array shoulder coil
3T HD Shoulder Array, A/B Port
3T HD Shoulder Array
1.5T HD Body Array
1.5T HD 8Ch Body Array
8 CHANNEL CARDIAC PHASED ARRAY COIL
1.5t 12 channel body array
1.5T 12 Ch Body Array HDx Single
1.5T 12 Ch Body Array HDx Dual
1.5T 12 Ch Body Array DV Single
insight 7000 phased array torso
QD C-SPINE COIL
1.5T 16ch AIR Anterior Array
1.5T 30ch AIR AA
1.5T 30ch AIR Anterior Array
1.5T AIR MP Large
1.5T AIR MP M
1.5T AIR MP Medium
1.5T 16ch AIR AA
1.5T AIR MP L
3T HNU
3T LAA
3T PET/MR CMA
3T UAA
SIGNA PET/MR
DISCOVERY MR 450-1.5T SPLIT HEAD COIL
Discovery MR450
Pediatric Positioner Pad Set
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device