ClearRead CT

Lung Computed Tomography System, Computer-aided Detection

RIVERAIN TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Riverain Technologies, Llc with the FDA for Clearread Ct.

Pre-market Notification Details

Device IDK161201
510k NumberK161201
Device Name:ClearRead CT
ClassificationLung Computed Tomography System, Computer-aided Detection
Applicant RIVERAIN TECHNOLOGIES, LLC 3020 SOUTH TECH BLVD. Miamisburg,  OH  45324
ContactJennifer Butsch
CorrespondentJennifer Butsch
RIVERAIN TECHNOLOGIES, LLC 3020 SOUTH TECH BLVD. Miamisburg,  OH  45324
Product CodeOEB  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-28
Decision Date2016-09-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M722CD25211V252110 K161201 000
M722CC25211V252110 K161201 000
M722C25211V252110 K161201 000

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