I_Space 1.5T Superconducting Magnetic Resonance Imaging System

System, Nuclear Magnetic Resonance Imaging

MRI Division, Beijing Wandong Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Mri Division, Beijing Wandong Medical Technology Co., Ltd. with the FDA for I_space 1.5t Superconducting Magnetic Resonance Imaging System.

Pre-market Notification Details

Device IDK192650
510k NumberK192650
Device Name:I_Space 1.5T Superconducting Magnetic Resonance Imaging System
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant MRI Division, Beijing Wandong Medical Technology Co., Ltd. No.7 Sanjianfang Nanli, Chaoyang District Beijing,  CN 100024
ContactZhou Lu
CorrespondentZhou Lu
MRI Division, Beijing Wandong Medical Technology Co., Ltd. No.7 Sanjianfang Nanli, Chaoyang District Beijing,  CN 100024
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-24
Decision Date2021-01-29

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