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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 K042041
Device Name XPLORER 1600
Applicant
IMAGING DYNAMICS COMPANY LIMITED
151,2340 PEGASUS WAY NE
CALGARY,  CA T3G3X5
Applicant Contact ROBIN WINSOR
Correspondent
IMAGING DYNAMICS COMPANY LIMITED
151,2340 PEGASUS WAY NE
CALGARY,  CA T3G3X5
Correspondent Contact ROBIN WINSOR
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/29/2004
Decision Date 09/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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