Devices

Optima MR450W with GEM.

Model / Serial
HM0227 HM0243 HM0245 HM0255 HM0290 HM0292 HM0296 HM0301 HM0315 HM0316 HM0321 HM0343 HM0271 HM0339 HMO293 HM0287 HM0263 HM0236 312 HM0322 HM0331 HM0332 357 HM0247 HM0250 HM0253 HM0261 HM0326 HMO300 HM0242 HM0249 HM0251 HM0254 HM0309 HM0310 HM0334 HM0338 HM0344 HM0347 HM0262 HM0323
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (Nationwide) including the states of :CO, FL, IA, MA ,MN, NJ, NY, NC, OH, TX. and the countries of BRAZIL., BRITAIN, FINLAND, FRANCE, GREAT GERMANY, ITALY, SAUDI ARABIA, SWEDEN, SPAIN, KUWAIT, and SWIITZERLAND.
Product Description
GE Healthcare, Optima MR450W with GEM. || Product Usage - The GEM Option for 1 .5T MRI systems is a set of receive-only RF surface coils designed for use with 1 .5T MRI systems manufactured by GE Healthcare. The GEM Option for 1 .5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.
Manufacturer
GE Healthcare, LLC
1 Event
- Recall of Optima MR450W with GEM.

Manufacturer

GE Healthcare, LLC

Manufacturer Address
GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
Manufacturer Parent Company (2017)
General Electric Company
Source
USFDA

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