MagicScan-1.5, GreenMR Serenity 1.5T— 510(k) K254250
Substantially EquivalentXingaoyi 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.
Summary
Xingaoyi Medical Equipment's submission lists MagicScan-1.5 and GreenMR Serenity 1.5T, filed under product code LNH, nuclear magnetic resonance imaging systems. The record doesn't say how the two names relate.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Xingaoyi filed from Yuyao, China. The decision came 231 calendar days after FDA received it (December 29, 2025 to August 17, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Xingaoyi Medical Equipment Co.,Ltd
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yuyao, CN
Recent devices under product code LNH
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . 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.