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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 K181565
Device Name Aquarius 8600 Digital Radiography Sensor
Applicant
Biokinemetrics Inc.
211 East 4th Street
Carroll,  IA  51401
Applicant Contact Steven Kraus
Correspondent
Biokinemetrics Inc.
211 East 4th Street
Carroll,  IA  51401
Correspondent Contact Steven Kraus
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
KPR  
Date Received06/14/2018
Decision Date 07/13/2018
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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