OIS SYMPHONY IMAGE MANAGMENT SYSTEM


Device Classification Name

system, image management, ophthalmic

510(k) Number K110006
Device Name OIS SYMPHONY IMAGE MANAGMENT SYSTEM
Applicant
OPHTHALMIC IMAGING SYSTEMS
221 lathrop way, suite i
sacramento, 
CA 
95815

Applicant Contact andrea ambrose
Correspondent
OPHTHALMIC IMAGING SYSTEMS
221 lathrop way, suite i
sacramento, 
CA 
95815

Correspodent Contact andrea ambrose
Regulation Number 892.2050
Classification Product Code
NFJ  
Date Received 01/03/2011
Decision Date 05/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No