TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS


Device Classification Name

tomography, optical coherence

510(k) Number K072971
Device Name TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
Applicant
TOPCON MEDICAL SYSTEMS, INC.
555 thirteenth st., nw
washington, 
DC 
20004

Applicant Contact jonathan s kahan
Correspondent
TOPCON MEDICAL SYSTEMS, INC.
555 thirteenth st., nw
washington, 
DC 
20004

Correspodent Contact jonathan s kahan
Regulation Number 886.1570
Classification Product Code
OBO  
Date Received 10/22/2007
Decision Date 01/13/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Clinical Trials NCT00792259
Reviewed by Third Party No

Combination Product

No