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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 K071402
Device Name X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM
Applicant
Imaging Dynamics Company , Ltd.
2340 Pegasus Way, NE
Suite 151
Calgary,  CA T2E 8M5
Applicant Contact SHIRANTHA SAMARAPPULI
Correspondent
Imaging Dynamics Company , Ltd.
2340 Pegasus Way, NE
Suite 151
Calgary,  CA T2E 8M5
Correspondent Contact SHIRANTHA SAMARAPPULI
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received05/21/2007
Decision Date 06/08/2007
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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