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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 K110332
Device Name CLEARCANVAS RIS / PACS
Applicant
Clearcanvas, Inc.
439 University Ave.
Suite 1920
Toronto, On,  CA M5G 1Y8
Applicant Contact CLINTON CHAU
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact PAULA WILKERSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/03/2011
Decision Date 03/24/2011
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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