(120 days)
AccuSoft is intended to be used for the computation, display, evaluation, and output documentation of radiation Treatment (IMRT) that thise for Thrensity arounded and clinical review and verification by a physicist or physician prior to use. The application provides output data in the form of displays or The application provides output a physician in selecting the bound by natucopy printouts to garao a personal provide a report to be used by patient treathent professional such as a radiation oncologist, a comportist, radiation therapist or dosimetrist.
AccuSoft is a radiation treatment planning system. It consists of a Software package that aloous and of extensive verification and produce radiation dose coundations to enable the proper system and patient setup and adequate radiation delivery. It includes the image, delineation and beam planning techniques. The it includes the miage, delineation beam enables the user to treat irregularly shaped lesions, maximizing the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures.
The provided text is a 510(k) summary for the AccuSoft radiation therapy treatment planning system. It discusses the device's intended use, description, and predicate devices, but it does not include a study describing acceptance criteria, device performance, or any of the detailed information requested in the prompt.
Therefore, I cannot provide the requested table and information as the provided text does not contain the necessary details. The document is primarily a regulatory submission for premarket notification, focusing on equivalence to existing devices rather than a detailed performance 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.