MagicScan-1.5, GreenMR Serenity 1.5T
FDA 510(k) K254250 · Xingaoyi Medical Equipment Co.,Ltd
510(k) numberK254250
Submission
- Device name
- MagicScan-1.5, GreenMR Serenity 1.5T
- Applicant
- Xingaoyi Medical Equipment Co.,Ltd
Yuyao, CN - Received
- December 29, 2025
- Decision date
- August 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional | Siemens Shenzhen Magnetic Resonance , Ltd. | 09/01/2026SE |
| K262622 | Swoop® Portable MR Imaging® SystemLNH · Special | Hyperfine, Inc. | 08/19/2026SE |
| K253808 | AIR Recon DLLNH · Traditional | GE Medical Systems | 08/13/2026SE |
| K261331 | I-Genius (100019400)LNH · Traditional | Esaote, S.p.A. | 07/31/2026SE |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional | Siemens Healthineers AG | 07/31/2026SE |
| K260113 | uMR AstraLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/22/2026SE |
| K253862 | APERTO Lucent MRI SystemLNH · Traditional | Fujifilm Corporation | 04/06/2026SE |
| K260746 | S-scan Open (100001800)LNH · Special | Esaote, S.p.A. | 03/27/2026SE |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional | Canon Medical Systems Corporation | 03/27/2026SE |
| K251937 | nordicAudio (1.0)LNH · Traditional | Nordicneurolab AS | 03/20/2026SE |
Questions and answers
When was MagicScan-1.5, GreenMR Serenity 1.5T cleared by the FDA?
MagicScan-1.5, GreenMR Serenity 1.5T (K254250) received a 510(k) decision of Substantially Equivalent on August 17, 2026, 231 days after the submission was received.
What is the product code of K254250?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.