OnQ Neuro

Automated Radiological Image Processing Software

CorTechs Labs, Inc

The following data is part of a premarket notification filed by Cortechs Labs, Inc with the FDA for Onq Neuro.

Pre-market Notification Details

Device IDK210831
510k NumberK210831
Device Name:OnQ Neuro
ClassificationAutomated Radiological Image Processing Software
Applicant CorTechs Labs, Inc 5060 Shoreham Place, Suite 240 San Diego,  CA  92122
ContactKora Marinkovic
CorrespondentKora Marinkovic
CorTechs Labs, Inc 5060 Shoreham Place, Suite 240 San Diego,  CA  92122
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-19
Decision Date2021-11-19

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