K254250
- 510(k) number
- K254250
- Device name
- MagicScan-1.5, GreenMR Serenity 1.5T
- Applicant
- Xingaoyi Medical Equipment Co.,Ltd CN
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2026-08-17
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K254250.pdf
Official FDA record: K254250
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.