# K240411: uAI Portal

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Intelligence Co., Ltd.
- Decided: Sep 6, 2024 after 207 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913770 (1991). 183 ancestors in all.
No later device cites it as a predicate yet.
3 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183170: uWS-CT, Shanghai United Imaging Healthcare Co., Ltd. (2019) Summary page 6.

## Indications for use
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 CTA. 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.

Source page: https://510kreport.com/device/K240411
Methodology: https://510kreport.com/methodology