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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 K063247
Device Name XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND
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 Received10/26/2006
Decision Date 11/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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