CARESTREAM PACS


Device Classification Name

system, image processing, radiological

510(k) Number K110919
Device Name CARESTREAM PACS
Applicant
CARESTREAM HEALTH, INC.
150 verona street
rochester, 
NY 
14608

Applicant Contact linda stewart
Correspondent
CARESTREAM HEALTH, INC.
150 verona street
rochester, 
NY 
14608

Correspodent Contact linda stewart
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/01/2011
Decision Date 10/20/2011
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