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FDA 510(k) K161201, ClearRead CT, by Riverain Technologies, LLC

FDA 510(k) K161201, ClearRead CT, by Riverain Technologies, LLC

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510(K) Number: K161201
Device Name: ClearRead CT
Manufacturer: Riverain Technologies, LLC
Device Classification Name: Lung Computed Tomography System, Computer-Aided Detection
Regulation Number: OEB
Classification Product Code: KXA
Date Received: 04/28/2016
Decision Date: 09/09/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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