Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“uOmnispace.CT is a software for viewing, manipulating, evaluating and analyzing medical images.”

AlgorithmML/AI method, deep learning-based

source quote (p.24)

“There are three algorithms based on ML/AI method: Spine labeling algorithm, Rib labeling algorithm, TAVR analysis algorithm”

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 of the proposed device results

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 of the proposed device results

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 the 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). 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).