GEM OPTION FOR 1.5 MRI SYSTEMS


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K103335
Device Name GEM OPTION FOR 1.5 MRI SYSTEMS
Applicant
GE HEALTHCARE
1515 danner dr.
aurora, 
OH 
44202

Applicant Contact michael s preto
Correspondent
GE HEALTHCARE
1515 danner dr.
aurora, 
OH 
44202

Correspodent Contact michael s preto
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 11/15/2010
Decision Date 03/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls