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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K062586
Device Name XPLORER 1600 PLUS
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
MQB  
Date Received09/01/2006
Decision Date 09/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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