K-number	K171201
Device name	NeuViz Prime Multi-slice CT Scanner System
Applicant	Neusoft Medical Systems Co., Ltd.
Product code	JAK
Device class	Class II
Decision date	Sep 13, 2017
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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NeuViz Prime Multi-slice CT Scanner System

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