uOmnispace.MR

K233186

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2024-04-17 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“uOmnispace.MR is a software solution intended to be used for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions.”
Algorithmdeep learning-based Automatic ventricular segmentation Algorithm
source quote (p.19)
“To validate the uOmnispace.MR software from a clinical perspective, the deep learning-based Automatic ventricular segmentation Algorithm for the LV&RV Contour Segmentation feature in MR Cardiac Function contained in the product underwent a scientific evaluation.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.18)
“These documentations include: • Software Description • Device Hazard Analysis • Software Requirements Specification (SRS) • Software Architecture Design Chart • Software Development Environment Description • Software Verification and Validation • Cybersecurity Documents”

Validation studies (1)

Retrospective clinical

n=114 patients

endpoints: Dice coefficient > 0.95 for consistency

standards: NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016)., ISO 14971 Medical devices - Application of risk management to medical devices (Edition 2.0, corrected version, 2007)., IEC 62304 Medical device software - Software life cycle processes (Edition 1.1, 2015).

Reported performance (1 observation)

diceas written: “Dice”1
source quote (p.20)
“The dice between the proposed and predicate device is 1.00 and shows the high consistency between the two devices.”

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242624 (decision 2025-05-14) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("Medical Image Post-processing Software (uOmnispace.CT)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242624

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233209 (decision 2024-05-17) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uOmnispace.CT") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233209

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/K233186