uAI Portal

K240411

Shanghai United Imaging Intelligence Co., Ltd. · cleared 2024-09-06 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“uAI Portal is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The Lower Extremity Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating CTA images of lower extremities. The Head and Neck Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with head and neck CТА. The Coronary Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with CCTA. The Pulmonary Artery Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with CTPA. The Aorta Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with aorta CTA.”
AlgorithmArtificial intelligence algorithms for automatic segmentation.
source quote (p.8)
“uAI Portal offers a fast and user-friendly solution for reconstructing medical images by utilizing automatic segmentation results generated by artificial intelligence algorithms.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.24)
“Those documentations include: • Software Description • Risk Management File • Software Requirements Specification (SRS) • Software Architecture Diagram • Software Development Environment Description • Software Verification and Validation • Software Version History • Cybersecurity Documents”

Validation studies (1)

Retrospective clinical

n=150 images

endpoints: Dice coefficient

standards: NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set, ISO 14971 Medical devices – Application of risk management to medical devices (Third Edition 2019-12), IEC 62304 Medical device software - Software life cycle processes (Edition 1.1 2015-06 CONSOLIDATED VERSION), Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Document issued on September 27, 2023)

Reported performance (9 observations)

diceas written: “Coronary Artery - Vessels segmentation Dice”0.92
source quote (p.26)
“Vessels segmentation 0.920”
diceas written: “Coronary Artery - Heart segmentation Dice”0.98
source quote (p.26)
“Heart segmentation 0.980”
diceas written: “Head and Neck Vessel - Head vessel segmentation Dice”0.902
source quote (p.26)
“Head vessel segmentation 0.902”
diceas written: “Head and Neck Vessel - Neck vessel segmentation Dice”0.967
source quote (p.26)
“Neck vessel segmentation 0.967”
diceas written: “Aorta - Trunk segmentation Dice”0.946
source quote (p.26)
“Trunk segmentation 0.946”
diceas written: “Aorta - Branches segmentation Dice”0.846
source quote (p.26)
“Branches segmentation 0.846”
diceas written: “Pulmonary Artery - Arteries segmentation Dice”0.953
source quote (p.26)
“Arteries segmentation 0.953”
diceas written: “Pulmonary Artery - Veins segmentation Dice”0.933
source quote (p.26)
“Veins segmentation 0.933”
diceas written: “Lower Extremity Artery - Arteries segmentation Dice”0.892
source quote (p.26)
“Arteries segmentation 0.892”

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
0
drift signals on this device

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/K240411