GE Healthcare Coils (USA Instruments, Inc.)
United StatesFDA applicant, unverified
- Devices
- 10
What GE Healthcare Coils (USA Instruments, Inc.) makes
The company manufactures magnetic resonance imaging (MRI) radiofrequency coils for 1.5T and 3.0T scanners, including head/neck/spine coils, body array coils (anterior/posterior), and pediatric positioning pads. Specialized coils include phased array cardiac coils and high-channel air-cooled arrays for whole-body imaging. Additional products include open-array designs for real-time imaging and pediatric-specific accessories.
These devices are classified under FDA 510(k) pathways as Class I or Class II medical devices. They are listed in the FDA’s 510(k) registry, reflecting their regulatory clearance status. The company is based in the United States.
Catalogue
48CH Head Coil Ref K163205
Regimes: 510(k) Registry: 510(k)48CH Head Coil Ref K180666
Regimes: 510(k) Registry: 510(k)1.5T Gem Rt Open Array Ref K123327
Regimes: 510(k) Registry: 510(k)3.0T 16 Channel Head Neck Spine Coil Ref K093348
Regimes: 510(k) Registry: 510(k)- Regimes: CE MDR 510(k) Registry: 510(k)
Pediatric Positioner Pad Set Ref K122174
Regimes: 510(k) Registry: 510(k)3.0T Air 32CH Hna Ref K253738
Regimes: 510(k) Registry: 510(k)3.0T GEM RT Open Array Ref K143389
Regimes: 510(k) Registry: 510(k)3.0T 16ch AIR AA Ref K223378
Regimes: CE MDR 510(k) Registry: 510(k)8 Channel Cardiac Phased Array Coil Ref K101492
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ge Healthcare Coils (Usa Instruments, Inc.) have in the registry?
The registry currently lists 10 devices for Ge Healthcare Coils (Usa Instruments, Inc.). Devices recorded under merged duplicate company entries are counted once.
Which registries list Ge Healthcare Coils (Usa Instruments, Inc.)'s devices?
Among its 10 most recently registered devices, Ge Healthcare Coils (Usa Instruments, Inc.) has devices listed in FDA 510(k) (10 devices).
What risk classes do Ge Healthcare Coils (Usa Instruments, Inc.)'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Ge Healthcare Coils (Usa Instruments, Inc.)'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ge Healthcare Coils (Usa Instruments, Inc.) in the registry?
The most recently registered devices listed for Ge Healthcare Coils (Usa Instruments, Inc.) include 48CH Head Coil, 1.5T GEM RT OPEN ARRAY, 3.0T 16 CHANNEL HEAD NECK SPINE COIL and DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A.