AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION


Device Classification Name

system, image processing, radiological

510(k) Number K110834
Device Name AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
Applicant
GE HEALTHCARE
3000 north.grandview blvd.
w1140
waukesha, 
WI 
53188

Applicant Contact helen peng
Correspondent
GE HEALTHCARE
3000 north.grandview blvd.
w1140
waukesha, 
WI 
53188

Correspodent Contact helen peng
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 03/25/2011
Decision Date 04/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls