AVIEW

AVIEW is a software system that analyzes CT thoracic and cardiac images to provide quantitative measurements of lung nodules, airways, and coronary arteries. It segments pulmonary structures, characterizes nodules with measurements like volume and density, calculates calcium scores for coronary risk assessment, and integrates with CAD software. The system stores and displays imaging data on-premises or in cloud environments accessible via mobile devices and browsers, intended for adult patients only.

AVIEW version 2.0 maintains the same technological characteristics as the predicate device in terms of materials, energy source, and control mechanisms. Software features have been modified with UI changes to various analysis pages (LAA, airway wall, fissure completeness, LCS, CAC), a new summary page, updated installation icons, and an added function to calculate arterial age based on Agatston score. The core intended use, indications, and algorithms remain unchanged from the predicate device.

Not stated in this summary.

The device is substantially equivalent because it maintains the same intended use and principle of operation as the predicate AVIEW (K214036), with no changes to core functionality or algorithms. The modifications are primarily user interface enhancements and operational environment changes that do not introduce new safety risks or raise questions of safety or effectiveness. Non-clinical testing supported by software validation and verification demonstrates the device performs equivalently, and no new scientific technology is introduced. Clinical testing was not required because the indications for use are identical to the predicate device.