VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM


Device Classification Name

automated digital image manual interpretation microscope

510(k) Number K111914
Device Name VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
Applicant
OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP
3500 corporate parkway
p.o. box 610
center valley, 
PA 
18034 -0610

Applicant Contact sheri l musgnung
Correspondent
OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP
3500 corporate parkway
p.o. box 610
center valley, 
PA 
18034 -0610

Correspodent Contact sheri l musgnung
Regulation Number 864.1860
Classification Product Code
OEO  
Date Received 07/06/2011
Decision Date 08/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Pathology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No