DISCOVERY MR750W 3.0T


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K103327
Device Name DISCOVERY MR750W 3.0T
Applicant
GE HEALTHCARE JAPAN CORPORATION
7-127, asahigaoka 4-chrome
hino-shi, tokyo, 

JP

191-8503

Applicant Contact toru shimizu
Correspondent
GE HEALTHCARE JAPAN CORPORATION
7-127, asahigaoka 4-chrome
hino-shi, tokyo, 

JP

191-8503

Correspodent Contact toru shimizu
Regulation Number 892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received 11/12/2010
Decision Date 09/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes

Recalls CDRH Recalls