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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 K161130
Device Name ResolutionMD
Applicant
Calgary Scientific, Inc.
Suite 208, 1210- 20th Ave. SE
Calgary,  CA T2G 1M8
Applicant Contact Kyle Peterson
Correspondent
Calgary Scientific, Inc.
Suite 208, 1210- 20th Ave. SE
Calgary,  CA T2G 1M8
Correspondent Contact Kyle Peterson
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/21/2016
Decision Date 08/24/2016
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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