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FDA 510(k)

MagicScan-1.5, GreenMR Serenity 1.5T

K-Number: K254250 · 2026-08-17

ApplicantXingaoyi Medical Equipment Co.,Ltd
Decision Date2026-08-17
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MagicScan-1.5, GreenMR Serenity 1.5T is the device name listed in this FDA 510(k) record. The listed applicant is Xingaoyi Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2026-08-17 under 510(k) number K254250. 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 MagicScan-1.5, GreenMR Serenity 1.5T?

MagicScan-1.5, GreenMR Serenity 1.5T is a medical device that received FDA 510(k) clearance on 2026-08-17. The listed applicant is Xingaoyi Medical Equipment Co.,Ltd. The 510(k) number is K254250.

When did MagicScan-1.5, GreenMR Serenity 1.5T receive FDA 510(k) clearance?

MagicScan-1.5, GreenMR Serenity 1.5T received FDA 510(k) clearance on 2026-08-17, under 510(k) number K254250.

Who is the listed applicant for MagicScan-1.5, GreenMR Serenity 1.5T?

The FDA 510(k) record lists Xingaoyi Medical Equipment Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagicScan-1.5, GreenMR Serenity 1.5T?

The FDA product code for MagicScan-1.5, GreenMR Serenity 1.5T is LNH.

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.

K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.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 Corporation

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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