uWS-Angio Basic

uWS-Angio Basic is image processing software designed to display and process X-Ray Angiographic (XA), Computed Tomography (CT), and Magnetic Resonance (MR) images that comply with the DICOM 3.0 protocol. It is intended for use in healthcare institutions to support viewing and post-processing of medical images from angiography systems and other sources, with functions including patient administration, 2D and 3D image review, measurement, calibration, and image saving/filming capabilities.

The proposed device shares the same fundamental technology and intended use as its predicate device (Syngo Application Software). Both are Class II medical image management and processing systems using DICOM protocol. The proposed device includes some additional functions (Synchronize Series and Crop Series) and fewer applications overall compared to the predicate, but these differences do not raise different safety or effectiveness questions. Performance testing demonstrated that the catheter calibration algorithm in uWS-Angio Basic has higher accuracy than the predicate, and CTA bone removal performs equivalently.

NEMA PS 3.1-3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2023e); 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).

The device is substantially equivalent because it shares identical indications for use, intended patient population, and clinical scenarios with the predicate device; both are Class II medical image management systems with the same product code (LLZ) and regulation number (21 CFR 892.2050). The proposed device's core functionality—displaying and processing DICOM-compliant medical images through basic processing tools—mirrors the predicate's fundamental operation. Although the proposed device includes fewer applications and two additional features, these differences do not alter safety or effectiveness profiles. Performance testing confirmed the device's key algorithms meet or exceed predicate performance standards, and comprehensive software verification and validation documentation was provided to support safety and efficacy.