(201 days)
Varian Treatment provides accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device from commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.
Varian Treatment is a software device that performs an interface role to the Siemens, GE, and Elekta linear accelerator systems. Varian Treatment (VT) allows treatment plans and reference images to be retrieved from the Varian System Database. VT sends the selected field of the loaded treatment plan down to the machine's treatment control software (TCS). VT verifies the field's planned parameters against the actual parameters of the TCS delivery system for accuracy before beam authorization is granted; this process is repeated for each field selected by the user. VT creates and transfers treatment records to the Varian System Database for storage.
The provided text is a 510(k) summary for the Varian Treatment device. This document primarily describes the device's function, indication for use, and regulatory classification. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information based on the given input. The document is a regulatory filing, not a scientific study report.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.