Motion Correction System

System, Nuclear Magnetic Resonance Imaging

KinetiCor, Inc.

The following data is part of a premarket notification filed by Kineticor, Inc. with the FDA for Motion Correction System.

Pre-market Notification Details

Device IDK193324
510k NumberK193324
Device Name:Motion Correction System
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant KinetiCor, Inc. 3465 Waialae Avenue, Suite 300A Honolulu,  HI  96816
ContactDoug Donzelli
CorrespondentScott R. Herr
KinetiCor, Inc. 3465 Waialae Avenue, Suite 300A Honolulu,  HI  96816
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-02
Decision Date2020-02-04

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