BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K073167
Device Name BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
Applicant
GE MEDICAL SYSTEMS, LLC
3200 n. grandview blvd.
waukesha, 
WI 
53188

Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 11/09/2007
Decision Date 01/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No