510(k) clearance
MagicScan-1.5, GreenMR Serenity 1.5T
- 510(k) number
- K254250
- Applicant
- Xingaoyi Medical Equipment Co.,Ltd
- Decision date
- Aug 17, 2026
- Date received
- Dec 29, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LNH
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Device class
- Class II
- Regulation
- 21 CFR 892.1000
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Yuyao, CN