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)
“Software verification and validation testing was provided to demonstrate safety and efficacy of the proposed device. This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern (LOC). Those documentations include: Software Description Device Hazard Analysis Software Requirements Specification (SRS) Software Architecture Design Chart Software Development Environment Description Software Verification and Validation Cybersecurity Documents”

Validation studies (0)

FDA source did not describe a validation study.

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
5
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K192601