Name: Predicase
Price: 199 USD

K-number	K192650
Device name	i_Space 1.5T Superconducting Magnetic Resonance Imaging System
Applicant	Mri Division,Beijing Wandong Medical Technology Co., Ltd.
Product code	LNH
Device class	Class II
Decision date	Jan 29, 2021
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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i_Space 1.5T Superconducting Magnetic Resonance Imaging System

Everything you need for a 510(k) submission. Nothing you don't.