Neuro.Al Algorithm

System, Image Processing, Radiological

TeraRecon, Inc.

The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Neuro.al Algorithm.

Pre-market Notification Details

Device IDK200750
510k NumberK200750
Device Name:Neuro.Al Algorithm
ClassificationSystem, Image Processing, Radiological
Applicant TeraRecon, Inc. 4309 Emperor Blvd., Suite 310 Durham,  NC  27703
ContactMegha Jain
CorrespondentPatrick Willhite
TeraRecon, Inc. 4309 Emperor Blvd., Suite 310 Durham,  NC  27703
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-23
Decision Date2020-11-06

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