(86 days)
The Apollo 5 and Apollo 10 In-Vivo Dosimetry systems are used to provide dose measurement capabilities for dose verification and quality assurance for patients undergoing radiation therapy.
Not Found
This document is a 510(k) clearance letter from the FDA for the Apollo 5 and Apollo 10 In-Vivo Dosimetry systems. It confirms that the devices are substantially equivalent to legally marketed predicate devices.
However, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request for that specific information based on the provided text. The letter only approves the devices for marketing and states their indications for use.
§ 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.