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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 K063267
Device Name ISITE PACS, V 4. X
Applicant
Stentor Inc., A Philips Medical Systems Co.
5000 Marina Blvd.
Suite 100
Brisbane,  CA  94005
Applicant Contact DEANA WISEMAN
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 Received10/30/2006
Decision Date 11/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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