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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 the device name listed in this FDA 510(k) record. The listed applicant is Mri Division,Beijing Wandong Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) 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. The listed applicant is Mri Division,Beijing Wandong Medical Technology Co., Ltd.. The 510(k) number is K221025.

When did i_ Field 1.5T Superconducting Magnetic Resonance Imaging System receive FDA 510(k) clearance?

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

Who is the listed applicant for i_ Field 1.5T Superconducting Magnetic Resonance Imaging System?

The FDA 510(k) record lists Mri Division,Beijing Wandong Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 37191776US regulatory considerations for low field magnetic resonance imaging systems.Magma (New York, N.Y.) (2023)

Other records listing Mri Division,Beijing Wandong Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192650i_Space 1.5T Superconducting Magnetic Resonance Imaging System

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

Official Source

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