uMR Omega with uWS-MR-MRS
K220332Shanghai United Imaging Healthcare Co.,Ltd. · cleared 2022-10-27 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“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. uWS-MR is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: ... Added Reconstruction method for certain sequences: AI-assisted Compressed Sensing, Compressed sensing.”
source quote (p.14)
“DeepRecon is a deep-learning based image processing algorithm for intelligent image de-noising and K-space-interpolation based image super-resolution.”
Validation studies (1)
Retrospective clinical
n=77 patients
endpoints: Image SNR; Image uniformity; Image contrast; clinical diagnosis quality
standards: ES 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2 Medical electrical equipment Part 1-2: General Requirements for basic safety and essential Performance, IEC 60601-2-33 Ed. 3.1:2013, Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic, ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity, ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization, MS 1-2008(R2020), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images, MS 3-2008(R2020), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images, MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging, MS 9-2008(R2020), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images, MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K252371 (decision 2025-09-25) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR 680") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K252371
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243397 (decision 2025-07-16) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR 680") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243397
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243122 (decision 2025-05-21) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR Omega") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243122
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K240744 (decision 2024-04-10) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR 680") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K240744
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K240540 (decision 2024-03-22) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR Omega") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K240540
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98779
- …and 1 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).