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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lung Computed Tomography System, Computer-Aided Detection
510(k) Number K161201
FOIA Releasable 510(k) K161201
Device Name ClearRead CT
Applicant
RIVERAIN TECHNOLOGIES, LLC
3020 SOUTH TECH BLVD.
Miamisburg,  OH  45324
Applicant Contact Jennifer Butsch
Correspondent
RIVERAIN TECHNOLOGIES, LLC
3020 SOUTH TECH BLVD.
Miamisburg,  OH  45324
Correspondent Contact Jennifer Butsch
Regulation Number892.2050
Classification Product Code
OEB  
Subsequent Product Code
LLZ  
Date Received04/28/2016
Decision Date 09/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT02440139
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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