(72 days)
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Not Found
The provided text is a 510(k) summary for the iPlan RT Dose system. It describes the device, its intended use, and its predicate devices, but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets them based only on the provided input. The document is an FDA approval letter and summary, not a 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.