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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 K171175
Device Name Aquarius 8600 1417WC
Applicant
Imaging Dynamics Company , Ltd.
#130, 5310-29th St. NE
Calgary,  CA T1Y 7E5
Applicant Contact Nicole Wherry
Correspondent
Imaging Dynamics Company , Ltd.
#130, 5310-29th St. NE
Calgary,  CA T1Y 7E5
Correspondent Contact Nicole Wherry
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/21/2017
Decision Date 10/05/2017
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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