(83 days)
The Proton IMMOBILIZATION Solution is indicated to assist in the proper positioning and repositioning of patients for radiation therapy and radiosurgery and treatment including electron, photon, and proton treatments.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for the "Proton Immobilization Solution" device. It does not contain any information regarding acceptance criteria, device performance, study details, or ground truth establishment.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. The "Indications for Use" section (page 2) describes the intended purpose of the device but does not include any performance metrics or study results.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.