uMR Omega

K243122

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2025-05-21 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD)”
AlgorithmSparkCo (Spark artifact Correction) is an algorithm that can detect and correct spark artifacts in MRI images. The spark detection module is based on AI algorithm, and the spark correction module is based on traditional parallel imaging reconstruction algorithm.
source quote (p.13)
“SparkCo (Spark artifact Correction) is an algorithm that can detect and correct spark artifacts in MRI images, which will help to restore spark-free image for clinical review when encountering spark artifacts on MRI images. 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. Then, the spark correction module based on traditional parallel imaging reconstruction algorithm will utilize the spark detection results to remove spark points and restore the full-sampled K-space. Through this two-step process, SparkCo can correct spark artifacts and restore the spark-free image.”
Adaptive (vs locked)FDA source did not state this
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 (2)

Retrospective clinical

n=15 patients

endpoints: spark detection accuracy; spark correction performance

Retrospective clinical

n=28 patients

endpoints: satisfaction rate S/(S+A+F)

Reported performance (1 observation)

accuracyas written: “spark detection accuracy”0.94
source quote (p.15)
“The average detection accuracy is 94%.”

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
4
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) 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

  • 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/K243122