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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 K062164
Device Name RESOLUTIONMD, VERSION 1.3
Applicant
Calgary Scientific, Inc.
1210 20th Ave. SE
Suite 208
Calgary, Alberta,  CA T2G 1M8
Applicant Contact PIERRE LEMIRE
Correspondent
Calgary Scientific, Inc.
1210 20th Ave. SE
Suite 208
Calgary, Alberta,  CA T2G 1M8
Correspondent Contact PIERRE LEMIRE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/28/2006
Decision Date 09/22/2006
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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