TCL3 Motion Tracking System

System, Nuclear Magnetic Resonance Imaging

Tracinnovations ApS

The following data is part of a premarket notification filed by Tracinnovations Aps with the FDA for Tcl3 Motion Tracking System.

Pre-market Notification Details

Device IDK203451
510k NumberK203451
Device Name:TCL3 Motion Tracking System
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Tracinnovations ApS World Trade Center Borupvang 3 DK-2750 Ballerup,  DK
ContactStefan Glimberg
CorrespondentSheila Pickering
Sheila Pickering PhD 2081 Longden Circle Los Altos,  CA  94024
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-04-28

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