GE Healthcare Coils

FDA Device Registration & Listing · AURORA, OH, US · Registration 1529041

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1529041
FEI Number
3005214683
Entity Name
GE Healthcare Coils
City/State/Country
AURORA, OH, US
Establishment Address
1515 DANNER DR, AURORA, OH 44202, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
GE HealthCare Technologies Inc. (Owner Number: 9912004)
Owner / Operator Contact Address
3000 N. Grandview Blvd, Waukesha, WI 53188, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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 1.5T SPLIT HEAD COIL 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 1.5T SPLIT HEAD COIL 3T SPLIT HEAD COIL 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 3T AA TDI POSTERIOR ARRAY TDI HEAD NECK ARRAY SIGNA Pioneer 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 3T SPLIT HEAD COIL 1.5T SPLIT HEAD COIL 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 TDI POSTERIOR ARRAY TDI HEAD NECK ARRAY SIGNA Pioneer 3T AA 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 SIGNA Voyager 1.5T TDI Posterior Array 1.5T Anterior Array 1.5T TDI Head Neck Array SIGNA Voyager Quantum 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 coil 3t 4-channel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2016-02-22
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2016-02-22
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2013-01-15
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2005-08-23
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-11-03
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2011-11-03
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2011-11-03
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2013-03-05
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2023-01-10
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2017-01-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2010-07-22
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2018-11-02
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2007-11-01
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2017-12-05
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-11-18
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2007-11-01
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2015-07-23
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2015-07-23
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2011-09-27
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2020-01-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2020-01-20
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2026-03-09
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-03-09
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-03-09
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2012-11-07
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2012-11-07
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2012-11-07
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-02-05
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
IXF Test-Pattern, Radiographic Radiology Class 1 892.1940 2003-10-07
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2018-04-13
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2017-01-04
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2017-01-04
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2011-03-23
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-02-21
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2011-02-21
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2011-03-23
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2016-09-06
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2016-09-06
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2010-07-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-07-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GE HealthCare Technologies Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007120336 GE Healthcare Magyarorszag Kft. Budapest, HU
3015060224 IMACTIS, SAS SAINT MARTIN D'HERES, FR
2122726 GE MEDICAL SYSTEMS, LLC Milwaukee, WI, US
9617766 GE BE PRIVATE LIMITED WHITEFIELD, BANGALORE Karnataka, IN
9710090 GE ULTRASOUND KOREA, LTD. Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K121249 Paramed S.R.L. MULTIARRAY KIT 2012-06-12
K000935 Mri Devices Corp. KFA-63 KNEE AND FOOT ARRAY 2000-04-07
K102889 Hitachi Medical Systems America, Inc. HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON 2010-12-20
K110373 Esaote, S.p.A. TEMPOROMANIBULAR COIL 15 2011-04-06
K030317 Midwest Rf, LLC MODEL 1300GE-64: PEDIATRIC POSITIONER 2003-03-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2020 Quality Electrodynamics LLC 2
TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Z-0032-2020 Quality Electrodynamics LLC 2
TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Z-0033-2020 Quality Electrodynamics LLC 2
TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Z-0034-2020 Quality Electrodynamics LLC 2
TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Z-0035-2020 Quality Electrodynamics LLC 2
TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525

Similar Registrations

Registration Number Establishment Name Location
3012169560 SIARON MEDICAL LTD Vancouver British Columbia, CA
3009077524 DHL SUPPLY CHAIN (NETHERLANDS) B.V. Beringe Limburg, NL
3010949642 GE HEALTHCARE (TIANJIN) COMPANY LIMITED Tianjin, CN
3006369484 NEOCOIL, LLC Pewaukee, WI, US
3010703925 MAKAR CONSULTING PTY LTD Belrose New South Wales, AU
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1529041. Last updated year: 2026. Please use registration number 1529041 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.