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FDA 510(k)

i_ Field 1.5T Superconducting Magnetic Resonance Imaging System

K-Number: K221025 · 2022-07-01

ApplicantMri Division,Beijing Wandong Medical Technology Co., Ltd.
Decision Date2022-07-01
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

i_ Field 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 2022-07-01 under approval number K221025. 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_ Field 1.5T Superconducting Magnetic Resonance Imaging System?

i_ Field 1.5T Superconducting Magnetic Resonance Imaging System is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Mri Division,Beijing Wandong Medical Technology Co., Ltd.. The 510(k) number is K221025.

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

i_ Field 1.5T Superconducting Magnetic Resonance Imaging System received FDA 510(k) clearance on 2022-07-01, under approval number K221025.

What company makes i_ Field 1.5T Superconducting Magnetic Resonance Imaging System?

i_ Field 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_ Field 1.5T Superconducting Magnetic Resonance Imaging System?

The FDA product code for i_ Field 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 NCT06868914 Phase I Trial of High-Density Theta Burst Stimulation (hdTBS) NOT_YET_RECRUITING NCT06762717 FARAPULSE™ Pulsed Field Ablation 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

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41839210 Artificial Intelligence in Radiology: Unlocking New Dimensions of Value. RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 41271017 Lymphedema Imaging and AI: A Review of Diagnostic Modalities, Biomarkers, and Clinical Integration. Biomedical journal (2025)

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

K192650i_Space 1.5T Superconducting Magnetic Resonance Imaging System

Related Devices (Code: LNH)

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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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