CENTRICITY CARDIO IMAGING


Device Classification Name

system, image processing, radiological

510(k) Number K112570
Device Name CENTRICITY CARDIO IMAGING
Applicant
GE HEALTHCARE INTEGRATED IT SOLUTIONS
540 w. nw highway
barrington, 
IL 
60010

Applicant Contact john manarik
Correspondent
GE HEALTHCARE INTEGRATED IT SOLUTIONS
540 w. nw highway
barrington, 
IL 
60010

Correspodent Contact john manarik
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/06/2011
Decision Date 11/30/2011
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