uMR 680

K240744

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2024-04-10 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.6)
“The uMR 680 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Standalone

sample size not stated

endpoints: Bias of accuracy; repeatability; reproducibility; parameter sensitivity shall fulfill with the design specification.

Retrospective clinical

sample size not stated

endpoints: Image quality is sufficient for diagnostic use.

Reported performance (2 observations)

accuracyas written: “Bias of accuracy”stated without value
source quote (p.8)
“Bias of accuracy, repeatability, reproducibility and parameter sensitivity shall fulfill with the design specification.”
sensitivityas written: “parameter sensitivity”stated without value
source quote (p.8)
“Bias of accuracy, repeatability, reproducibility and parameter sensitivity shall fulfill with the design specification.”

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

100
recalls in product code, 24mo
510
MAUDE reports in code, 12mo
+5%
vs code's own 3-yr baseline
8
drift signals on this device
  • 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) K250246 (decision 2025-08-05) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR Jupiter") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250246

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243547 (decision 2025-07-17) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR Ultra") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243547

  • 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) K233673 (decision 2024-04-26) from Shanghai United Imaging Healthcare Co., Ltd for a matching device line ("uMR Jupiter") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233673

  • …and 2 more.

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/K240744