VB IMAGE VIEWER


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K080581
Device Name VB IMAGE VIEWER
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley, 
PA 
18034

Applicant Contact laura storms-tyler
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley, 
PA 
18034

Correspodent Contact laura storms-tyler
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 03/03/2008
Decision Date 10/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No