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.”

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)

“• Cybersecurity Documents”

Validation studies (1)

Retrospective clinical

n=114 patients

endpoints: Sørensen-Dice coefficient > 0.95

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: “Average 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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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). 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).