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
Coil, Magnetic Resonance, Specialty MOS
System, Nuclear Magnetic Resonance Imaging LNH
System, Nuclear Magnetic Resonance Spectroscopic LNI
Test-Pattern, Radiographic IXF
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance OUO
Cradle, Patient, Radiologic KXH

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