THORACIC VCAR


Device Classification Name

system, image processing, radiological

510(k) Number K103480
Device Name THORACIC VCAR
Applicant
GE MEDICAL SYSTEMS, LLC
3000 n grandview
waukesha, 
WI 
53188

Applicant Contact stephen slavens
Correspondent
GE MEDICAL SYSTEMS, LLC
3000 n grandview
waukesha, 
WI 
53188

Correspodent Contact stephen slavens
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 11/26/2010
Decision Date 03/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No