CARDIAC VX


Device Classification Name

system, image processing, radiological

510(k) Number K121762
Device Name CARDIAC VX
Applicant
GE MEDICAL SYSTEMS, LLC
3200 n. grandview blvd.
waukesha, 
WI 
53188

Applicant Contact michelle huettner
Correspondent
GE MEDICAL SYSTEMS, LLC
3200 n. grandview blvd.
waukesha, 
WI 
53188

Correspodent Contact michelle huettner
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 06/15/2012
Decision Date 01/18/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Clinical Trials NCT00877903
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls