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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K080581
Device Name VB IMAGE VIEWER
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact LAURA STORMS-TYLER
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/03/2008
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
Predetermined Change
Control Plan Authorized		 No
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