(210 days)
The P-ART device is designed to achieve patient correct geometric positioning with respect to a treatment device based on the specification of one or more successive treatment field prescriptions.
Not Found
This is a 510(k) clearance letter for the P-ART device, not a study report. The document indicates that the device has been found substantially equivalent to a predicate device but does not contain the detailed clinical study information requested. Therefore, I cannot provide a response to your request for acceptance criteria and study details 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.