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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K061595
Device Name XAMINER
Applicant
Imaging Dynamics Company , Ltd.
151,2340 Pegasus Way, NE
Calgary, Alberta,  CA T2E 8M5
Applicant Contact SHIRANTHA SAMARAPPULI
Correspondent
Imaging Dynamics Company , Ltd.
151,2340 Pegasus Way, NE
Calgary, Alberta,  CA T2E 8M5
Correspondent Contact SHIRANTHA SAMARAPPULI
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received06/08/2006
Decision Date 08/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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