BrainInsight

System, Image Processing, Radiological

Hyperfine Research, Inc

The following data is part of a premarket notification filed by Hyperfine Research, Inc with the FDA for Braininsight.

Pre-market Notification Details

Device IDK202414
510k NumberK202414
Device Name:BrainInsight
ClassificationSystem, Image Processing, Radiological
Applicant Hyperfine Research, Inc 530 Old Whitfield St. Guilford,  CT  06437
ContactRobert Fasciano
CorrespondentRobert Fasciano
Hyperfine Research, Inc 530 Old Whitfield St. Guilford,  CT  06437
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-24
Decision Date2021-01-07

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