uMR 780

K193176

Shanghai United Imaging Healthcare Co., Ltd · cleared 2020-05-05 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.4)

“The uMR 780 is a 3.0T superconducting magnetic resonance diagnostic device with a 65cm 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.”

AlgorithmAI-assisted compressed sensing

source quote (p.5)

“AI-assisted compressed sensing.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: Spectroscopy; Computed DWI; AI-assisted compressed sensing

standards: NEMA, DICOM

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

100

recalls in product code, 24mo

510

MAUDE reports in code, 12mo

+5%

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) 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 5 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).