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The Tracker / August 2026 / K254250

510(k) cleared

MagicScan-1.5, GreenMR Serenity 1.5T

Xingaoyi Medical Equipment Co.,Ltd · Aug 17, 2026 · K254250

FDA cleared the MagicScan-1.5, GreenMR Serenity 1.5T from Xingaoyi Medical Equipment Co.,Ltd on Aug 17, 2026 under K254250, a traditional 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 29, 2025. The decision came 231 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Xingaoyi Medical Equipment Co.,Ltd in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254250?

K254250 is the FDA 510(k) for MagicScan-1.5, GreenMR Serenity 1.5T, submitted by Xingaoyi Medical Equipment Co.,Ltd. FDA's decision date was Aug 17, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the MagicScan-1.5, GreenMR Serenity 1.5T?

Xingaoyi Medical Equipment Co.,Ltd, based in Yuyao, is the applicant of record for K254250.

How long did the K254250 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Aug 17, 2026, 231 days later.

← All decisions in August 2026