uWS-MR

K192601

Shanghai United Imaging Healthcare Co., Ltd · cleared 2020-06-01 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“uWS-MR is a comprehensive software solution designed to process, review and analyze MR (Magnetic Resonance Imaging) studies. It can be used as a stand-alone SaMD or a post processing application option for cleared UIH (Shanghai United Imaging Healthcare Co.,Ltd.) MR Scanners.”

AlgorithmFDA source did not state this

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.13)

“Cybersecurity Documents”

Validation studies (2)

Bench

sample size not stated

endpoints: safety and efficacy

standards: NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016), ISO 14971 Medical devices – Application of risk management to medical devices (Edition 2.0, corrected version, 2007), IEC 62304 Medical device software - Software life cycle processes (Edition 1.1, 2015)

Bench

sample size not stated

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K253173 (decision 2026-01-20) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uCT 780 with uWS-CT-Dual Energy Analysis") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253173
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243617 (decision 2025-05-16) from Shanghai United Imaging Healthcare Co.,Ltd. for a matching device line ("uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243617
re_clearance
The FDA AI/ML device list shows a newer 510(k) K223028 (decision 2023-02-16) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uCT ATLAS Astound with uWS-CT-Dual Energy Analysis") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K223028
re_clearance
The FDA AI/ML device list shows a newer 510(k) K220332 (decision 2022-10-27) from Shanghai United Imaging Healthcare Co.,Ltd. for a matching device line ("uMR Omega with uWS-MR-MRS") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K220332
re_clearance
The FDA AI/ML device list shows a newer 510(k) K203448 (decision 2021-08-11) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uCT ATLAS with uWS-CT-Dual Energy Analysis") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K203448

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).