uMR Omega

K240540

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2024-03-22 · 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) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (6)

Bench

sample size not stated

endpoints: The maximum temperature of all temperature probes shall not exceed 41°C.

standards: NEMA MS 14

Bench

sample size not stated

endpoints: Conform with ANSI/AAMI ES60601-1

standards: ANSI/AAMI ES60601-1

Bench

sample size not stated

endpoints: SNR and Uniformity shall fulfill the design specification.

standards: NEMA MS 1, NEMA MS 3, NEMA MS 6, NEMA MS 9

Bench

sample size not stated

endpoints: All the materials of patient-contacting components for the Breast Coil - 24 are identical to uMR Omega which was cleared in K230152 in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).

standards: ISO 10993-1

Bench

sample size not stated

endpoints: Conform with IEC 60601-1-2 and IEC 60601-4-2

standards: IEC 60601-1-2, IEC 60601-4-2

Bench

sample size not stated

endpoints: Image quality is sufficient for diagnostic use.

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
6
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

  • 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) K240744 (decision 2024-04-10) 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:K240744

  • 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/K240540