# K243122: uMR Omega

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: May 21, 2025 after 233 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: 18 generations back to K971684 (1997). 42 ancestors in all.
2 later devices descend from it; 1 cites it directly.
4 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240540: uMR Omega, Shanghai United Imaging Healthcare Co., Ltd. (2024) Summary page 5.
- K230152: uMR Omega, Shanghai United Imaging Healthcare Co., Ltd. (2023) Summary page 5.
- K220332: uMR Omega with uWS-MR-MRS, Shanghai United Imaging Healthcare Co., Ltd. (2022) Summary page 5.

## Most influential descendants
- K243547: uMR Ultra (2025), 1 descendant of its own
- K260113: uMR Astra (2026), 0 descendants of its own

## Indications for use
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic 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 diagnosis. Contrast agents may be used depending on the region of interest of the scan.

Source page: https://510kreport.com/device/K243122
Methodology: https://510kreport.com/methodology