MagicScan-1.5, GreenMR Serenity 1.5T— 510(k) K254250

Name: FDA 510(k) clearance K254250
Creator: U.S. Food and Drug Administration
Published: 2026-08-17

Substantially Equivalent

Xingaoyi Medical Equipment Co.,Ltd

FDA 510(k) clearance K254250 for MagicScan-1.5, GreenMR Serenity 1.5T, Substantially Equivalent on 2026-08-17. Applicant: Xingaoyi Medical Equipment Co.,Ltd. Device class: 2.

Clearance details

Applicant: Xingaoyi Medical Equipment Co.,Ltd
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2025-12-29
Decision date: 2026-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yuyao, CN

Download summary PDF View on FDA.gov ↗

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K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31
K261331 — I-Genius (100019400)2026-07-31
K260113 — uMR Astra2026-05-22

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.