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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K030635
Device Name THE OBSIDIAN PACS SYSTEM
Applicant
OBSIDIAN MEDICAL TECHNOLOGY, INC.
5108 CORONA CT.
PLEASANTON,  CA  94588
Applicant Contact BIANCA GREEN
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact LAURA DANIELSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/28/2003
Decision Date 03/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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