CENTRICITY PACS


Device Classification Name

system, image processing, radiological

510(k) Number K110875
Device Name CENTRICITY PACS
Applicant
GE HEALTHCARE
540 w. northwest highway
barrington, 
IL 
60010

Applicant Contact cheryl bork
Regulation Number 892.2050
Classification Product Code
LLZ  
Subsequent Product Code
GCJ  
Date Received 03/30/2011
Decision Date 05/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No