BodyTom 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 Bodytom Elite.

Pre-market Notification Details

Device IDK170238
510k NumberK170238
Device Name:BodyTom 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 Received2017-01-26
Decision Date2017-06-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10815411020311 K170238 000

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