CARESTREAM VUE PACS


Device Classification Name

system, image processing, radiological

510(k) Number K122523
Device Name CARESTREAM VUE PACS
Applicant
CARESTREAM HEALTH, INC.
150 verona street
rochester, 
NY 
14608

Applicant Contact alexandra chamberlain
Correspondent
CARESTREAM HEALTH, INC.
150 verona street
rochester, 
NY 
14608

Correspodent Contact alexandra chamberlain
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 08/20/2012
Decision Date 10/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No