uMR 680

K243397

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2025-07-16 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
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. Addition of imaging reconstruction methods: AI-assisted Compressed Sensing (ACS), Spark artifact Correction (SparkCo).”
AlgorithmAI-assisted Compressed Sensing and AI-based spark detection, as well as algorithms for ED/ES Phases Recognition, ECV, and MOCO
source quote (p.14)
“ACS (AI-assisted Compressed Sensing) is an acceleration reconstruction technique. By adding one more regularization term from Al module, ACS is a slight extension of CS (Compressed Sensing). The spark detection module of SparkCo is based on the AI algorithm, however, it won't change the image directly, and it only provides the K-space location of spark points.”
Adaptive (vs locked)No
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.13)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

Validation studies (6)

Retrospective clinical

n=1,724 images

endpoints: NRMSE; SNR; Resolution (SD/mean value); ROI signal intensities; Image Uniformity; Structure Measurement; Clinical diagnosis quality

standards: NEMA MS 6-2008(R2004)

Retrospective clinical

n=59 cases

endpoints: detection accuracy; PSNR (Peak signal-to-noise ratio) of the spark-corrected images and original spark images; image quality improvement

Retrospective clinical

n=95 cases

endpoints: error between phase indices and gold standard phase indices

Retrospective clinical

n=90 images

endpoints: satisfaction rate S/(S+A+F) exceeding 95%

Retrospective clinical

n=105 cases

endpoints: average Dice coefficient of the left ventricular myocardium after motion correction

Retrospective clinical

n=182 cases

endpoints: average Dice coefficient of the left ventricular myocardium after motion correction

Reported performance (3 observations)

accuracyas written: “SparkCo Average detection accuracy”0.94
source quote (p.18)
“The average detection accuracy is 94%.”
diceas written: “Inline MOCO (Cardiac Perfusion) Average Dice coefficient”0.92
source quote (p.25)
“The average Dice coefficient of the left ventricular myocardium after motion correction is 0.92, which is greater than 0.87.”
diceas written: “Inline MOCO (Cardiac Dark Blood) Average Dice coefficient”0.96
source quote (p.25)
“The average Dice coefficient of the left ventricular myocardium after motion correction is 0.96, which is greater than 0.87.”

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
5
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

  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98111

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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K243397