BodyTom 64

System, X-ray, Tomography, Computed

NeuroLogica Corporation,

The following data is part of a premarket notification filed by Neurologica Corporation, with the FDA for Bodytom 64.

Pre-market Notification Details

Device IDK213649
510k NumberK213649
Device Name:BodyTom 64
ClassificationSystem, X-ray, Tomography, Computed
Applicant NeuroLogica Corporation, a Subsidiary Of Samsung Electronics Co., Ltd 14 Electronics Avenue Danvers,  MA  01923
ContactNinad Gujar
CorrespondentNinad Gujar
NeuroLogica Corporation, a Subsidiary Of Samsung Electronics Co., Ltd 14 Electronics Avenue Danvers,  MA  01923
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-19
Decision Date2022-04-29

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