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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 K042292
Device Name ISITE PACS
Applicant
STENTOR, INC.
5000 MARINA BLVD. SUITE 100
brisbane,  CA  94005 -1330
Applicant Contact deana wiseman
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
new brighton,  MN  55112 -1891
Correspondent Contact cheryl norton
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/24/2004
Decision Date 09/08/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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