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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 K170202
Device Name Aquarius 8600
Applicant
IMAGING DYNAMICS COMPANY LTD.
130, 3510 29th St. NE
Calgary,  CA T1Y 7E5
Applicant Contact Nicole Wherry
Correspondent
IMAGING DYNAMICS COMPANY LTD.
130, 3510 29th St. NE
Calgary,  CA T1Y 7E5
Correspondent Contact Nicole Wherry
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
KPR  
Date Received01/23/2017
Decision Date 02/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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