uWS-Angio Basic
Shanghai United Imaging Healthcare Co., Ltd.uWS-Angio Basic is medical image management and processing software designed to handle X-ray angiographic, CT, and MRI images. It provides clinicians with tools for viewing, processing, calibration, and measurement of 2D and 3D vascular images, supporting improved diagnosis and treatment planning in angiography and related procedures.
Intended Use
Intended to display and process XA (X-Ray Angiographic), CT (Computed Tomography), and MR (Magnetic Resonance) images that comply with the DICOM 3.0 protocol.
Technology
uWS-Angio Basic is an image processing software designed for vascular angiography machines. It supports patient administration, 2D image viewing and processing including DSA image handling, 3D image viewing and processing with CTA bone removal, saving, and filming. It can be deployed standalone or in networked environments within United Imaging Angiography systems.
Performance
Performance testing included software verification and validation, hazard analysis, and specific algorithm evaluations for catheter calibration and CTA bone removal. Testing demonstrated that catheter calibration has high accuracy with error rates lower than the predicate device, and performance of CTA bone removal is comparable to predicate devices. No animal or clinical studies were required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/25/2024
5 months - 2
FDA Approval
5/12/2025
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
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