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. ACS (AI-assisted Compressed Sensing) is an acceleration reconstruction technique.”
AlgorithmAI-assisted Compressed Sensing (ACS) is an acceleration reconstruction technique. SparkCo is an algorithm that can detect and correct spark artifacts in MRI images. Inline ED/ES phases recognition algorithm. Inline ECV algorithm. Inline MOCO algorithm.
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).”
Adaptive (vs locked)No
source quote (p.14)
“The training dataset of AI module in ACS was collected from a variety of anatomies, image contrasts, and acceleration factors.”
PCCPNo
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); Image Contrast (ROI signal intensities, Bland-Altman analysis); Image Uniformity; Structure Measurement; Diagnosis quality (radiologist evaluation)

standards: NEMA MS 6-2008(R2004)

Retrospective clinical

n=59 cases

endpoints: Detection accuracy; PSNR (Peak signal-to-noise ratio); Image quality improvement

Retrospective clinical

n=95 cases

endpoints: Error between phase indices

Retrospective clinical

n=90 images

endpoints: Segmentation accuracy (myocardial boundary adherence, blood pool ROI inclusion)

Retrospective clinical

n=105 cases

endpoints: Dice coefficient of the left ventricular myocardium

Retrospective clinical

n=182 cases

endpoints: Dice coefficient of the left ventricular myocardium

Reported performance (3 observations)

accuracyas written: “Spark detection accuracy”0.94
source quote (p.18)
“The average detection accuracy is 94%.”
diceas written: “Average Dice coefficient (Cardiac Perfusion)”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: “Average Dice coefficient (Cardiac Dark Blood)”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); 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/K243397