# K254250: MagicScan-1.5, GreenMR Serenity 1.5T

- Pathway: 510(k) (Traditional)
- Applicant: Xingaoyi Medical Equipment Co.,Ltd
- Decided: Aug 17, 2026 after 231 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K183137 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183137: uMR 580, uMR 588, Shanghai United Imaging Healthcare Co., Ltd. (2019) Summary page 6.

## Indications for use
The MagicScan-1 .5, GreenMR Serenity 1.5T system is indicated for use as a Magnetic Resonance Imaging System that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnostic. Contrast agents may be used depending on the region of interest of the scan.

Source page: https://510kreport.com/device/K254250
Methodology: https://510kreport.com/methodology