ChartCheck (RADCH V1.6)

ChartCheck (RADCH V1.6) is a software application that assists trained radiation oncology personnel in performing quality assessments of radiotherapy treatment plans and on-treatment reviews. It integrates plan, treatment, imaging, and documentation data from oncology information systems to enable medical physicists to review treatment records, visualize on-treatment imaging, calculate doses, and approve chart checks.

ChartCheck (RADCH V1.6) is a Windows-based software-only application with three main components: an agent service monitoring the OIS database, a checking service comparing treatment records to plans and processing imaging data, and a web application providing chart checking, image viewing, and administrative settings. New functionality includes synthetic CT generation from on-treatment images (CBCT) and planning CT, on-treatment dose calculation using machine log files, and deformable registration capabilities leveraging cleared algorithms from reference devices.

Not stated in this summary.

ChartCheck (RADCH V1.6) is substantially equivalent to the predicate device ChartCheck (K201119) because it maintains the same indications for use, intended users (trained radiation oncology personnel), and regulatory classification (Rx, Class II). The device reuses cleared methods and libraries from reference devices (ClearCheck K220583 for dose constraint objectives, ClearCalc K220582 for dose calculation, AutoContour K242729 for registration, and Velocity K173636 for synthetic image generation). Verification and validation testing demonstrated that the software functions as intended with equivalent outputs to clinically-utilized systems, and the minor technological differences do not raise safety or effectiveness concerns.