SIGNA 3.0T MR750 SYSTEM


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K081028
Device Name SIGNA 3.0T MR750 SYSTEM
Applicant
GE MEDICAL SYSTEMS, LLC
3200 n. grandview blvd.
waukesha, 
WI 
53188

Applicant Contact mark stauffer
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 04/11/2008
Decision Date 04/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls