OmniTom Elite

System, X-ray, Tomography, Computed

NeuroLogica Corporation, A Subsidiary Of Samsung Electronics

The following data is part of a premarket notification filed by Neurologica Corporation, A Subsidiary Of Samsung Electronics with the FDA for Omnitom Elite.

Pre-market Notification Details

Device IDK202526
510k NumberK202526
Device Name:OmniTom Elite
ClassificationSystem, X-ray, Tomography, Computed
Applicant NeuroLogica Corporation, A Subsidiary Of Samsung Electronics 14 Electronics Avenue Danvers,  MA  01923
ContactNinad Gujar
CorrespondentNinad Gujar
NeuroLogica Corporation, A Subsidiary Of Samsung Electronics 14 Electronics Avenue Danvers,  MA  01923
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-01
Decision Date2020-12-23

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