CARA


Device Classification Name

system, image management, ophthalmic

510(k) Number K110869
Device Name CARA
Applicant
DIAGNOS, INC
300 brickstone square
andover, 
MA 
01810

Applicant Contact aron shapiro
Correspondent
DIAGNOS, INC
300 brickstone square
andover, 
MA 
01810

Correspodent Contact aron shapiro
Regulation Number 892.2050
Classification Product Code
NFJ  
Date Received 03/29/2011
Decision Date 07/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No