ClearRead CT— 510(k) K161201

Substantially Equivalent

Riverain Technologies, LLC

FDA 510(k) clearance K161201 for ClearRead CT, Substantially Equivalent on 2016-09-09. Applicant: Riverain Technologies, LLC. Device class: 2.

Clearance details

Applicant: Riverain Technologies, LLC
Product code: Code OEB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2016-04-28
Decision date: 2016-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, US

Download summary PDF View on FDA.gov ↗

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