VIEWPOINT 6


Device Classification Name

system, image processing, radiological

510(k) Number K103458
Device Name VIEWPOINT 6
Applicant
GE HEALTHCARE
3000 north grandview blvd
#w450
waukesha, 
WI 
53188

Applicant Contact nicole landreville
Correspondent
GE HEALTHCARE
3000 north grandview blvd
#w450
waukesha, 
WI 
53188

Correspodent Contact nicole landreville
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 11/23/2010
Decision Date 03/04/2011
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