DRYVIEW CHROMA IMAGING SYSTEM


Device Classification Name

camera, multi format, radiological

510(k) Number K111566
Device Name DRYVIEW CHROMA IMAGING SYSTEM
Applicant
CARESTREAM HEALTH,INC.
150 verona street
rochester, 
NY 
14608

Applicant Contact christine ehamnn
Correspondent
CARESTREAM HEALTH,INC.
150 verona street
rochester, 
NY 
14608

Correspodent Contact christine ehamnn
Regulation Number 892.2040
Classification Product Code
LMC  
Date Received 06/06/2011
Decision Date 10/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No