Cleerly Labs

System, Image Processing, Radiological

Cleerly Inc

The following data is part of a premarket notification filed by Cleerly Inc with the FDA for Cleerly Labs.

Pre-market Notification Details

Device IDK190868
501k NumberK190868
Device Name:Cleerly Labs
ClassificationSystem, Image Processing, Radiological
Applicant Cleerly Inc 101 Greenwich St, Suite 11C New York,  NY  10006
ContactKimberly Elmore
CorrespondentKimberly Elmore
Cleerly Inc 101 Greenwich St, Suite 11C New York,  NY  10006
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-03
Decision Date2019-11-05

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