DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K103365
Device Name DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A
Applicant
GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
1515 danner dr
aurora, 
OH 
44202 -9273

Applicant Contact michael s preto
Correspondent
GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
1515 danner dr
aurora, 
OH 
44202 -9273

Correspodent Contact michael s preto
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 11/17/2010
Decision Date 01/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No