Search Results

Vision is a plan and image management application that is intended to enable an authorized user to enter, access, modify, store and archive plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments. The preparation tasks include image acquisition, viewing and manipulation, and treatment plan definition, manipulation and scheduling.

The name Varis Images has changed to Vision. The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive plan and image data from diagnositic studies, treatment planning, simulation, plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

The provided text describes the "Vision" (formerly Varis Images) product, a plan and image management application for radiotherapy. However, it does not contain any information about acceptance criteria, device performance, a study conducted to prove it meets acceptance criteria, or any details related to sample sizes, ground truth establishment, or expert involvement in such a study.

The document is a 510(k) summary for a legacy device (K042956, submitted in 2004, cleared in 2005) which focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It is not a performance study report.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other specifics about a study proving the device meets acceptance criteria. The document explicitly states: "The Substantial Equivalence 6. Comparison Chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Tab 9 of the submission." This indicates that the regulatory submission primarily relied on comparing its features to existing, cleared devices rather than providing a new clinical or performance study.

Ask a specific question about this device