uOmnispace

K230039

Shanghai United Imaging Healthcare Co., Ltd · cleared 2023-07-20 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“uOmnispace is a software only medical device, the hardware itself is not seen as part of the medical device and therefore not in the scope of this product.”
AlgorithmMachine Learning based algorithm
source quote (p.5)
“Rib extraction algorithm is based on Machine Learning. To validate the uOmnispace software from a clinical perspective, the ML-based rib segmentation algorithm 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.13)
“Cybersecurity Documents”

Validation studies (1)

Retrospective clinical

n=60 patients

endpoints: The average dice of testing data is higher than 0.8

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”0.855
source quote (p.15)
“The average dice on testing data set is 0.855, which is higher than 0.8.”

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
4
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233186 (decision 2024-04-17) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uOmnispace.MR") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233186

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233176 (decision 2023-12-20) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uOmnispace.MI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233176

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/K230039