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FDA 510(k)

i_Space 1.5T Superconducting Magnetic Resonance Imaging System

K-Number: K192650 · 2021-01-29

ApplicantMri Division,Beijing Wandong Medical Technology Co., Ltd.
Decision Date2021-01-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

i_Space 1.5T Superconducting Magnetic Resonance Imaging System is a medical device manufactured by Mri Division,Beijing Wandong Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-29 under approval number K192650. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i_Space 1.5T Superconducting Magnetic Resonance Imaging System?

i_Space 1.5T Superconducting Magnetic Resonance Imaging System is a medical device that received FDA 510(k) clearance on 2021-01-29. It is manufactured by Mri Division,Beijing Wandong Medical Technology Co., Ltd.. The 510(k) number is K192650.

When was i_Space 1.5T Superconducting Magnetic Resonance Imaging System approved by the FDA?

i_Space 1.5T Superconducting Magnetic Resonance Imaging System received FDA 510(k) clearance on 2021-01-29, under approval number K192650.

What company makes i_Space 1.5T Superconducting Magnetic Resonance Imaging System?

i_Space 1.5T Superconducting Magnetic Resonance Imaging System is manufactured by Mri Division,Beijing Wandong Medical Technology Co., Ltd..

What is the FDA product code for i_Space 1.5T Superconducting Magnetic Resonance Imaging System?

The FDA product code for i_Space 1.5T Superconducting Magnetic Resonance Imaging System is LNH.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT04345003 MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids COMPLETED NCT06577454 Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder SUSPENDED NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT00109174 MRS Measurement of Glutamate and GABA Metabolism in Brain RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 37191776 US regulatory considerations for low field magnetic resonance imaging systems. Magma (New York, N.Y.) (2023)

Other Devices by Mri Division,Beijing Wandong Medical Technology Co., Ltd.

K221025i_ Field 1.5T Superconducting Magnetic Resonance Imaging System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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