(49 days)
TrackPort is an online EPID intended to aid in target-to-beam relative positioning for administration of radiotherapy. It is indicated for all body procedures and operable in conjunction with TrackLeaf Micro Multi Leaf Collimating (MMLC) system
TrackPort
The provided text is a 510(k) premarket notification letter from the FDA to Direx Systems Corp. regarding their device, TrackPort. This document confirms substantial equivalence but does not contain information about the acceptance criteria or a study proving the device meets those criteria. It primarily focuses on the regulatory approval and indications for use.
Therefore, I cannot extract 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.