uOmnispace.CT

K233209

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2024-05-17 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“uOmnispace.CT is a software for viewing, manipulating, evaluating and analyzing medical images.”
Algorithmdeep learning-based, AI-based
source quote (p.24)
“The performance testing for deep learning-based spine labeling algorithm was performed on 120 subjects (data shown in Table 8-2) during the product development. The performance testing for the AI-based TAVR analysis algorithm was performed on 60 subjects (data shown in Table 8-8) during the product development.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.24)
“Cybersecurity Documents”

Validation studies (3)

Retrospective clinical

n=120 patients

endpoints: Average score based on ground truth

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)

Retrospective clinical

n=120 patients

endpoints: Average score based on ground truth

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)

Retrospective clinical

n=60 patients · 2 site(s)

endpoints: Mean landmark error; Average score of evaluation criteria

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 (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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
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

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/K233209