(161 days)
The intended use of this Air-Bag System is to monitor patient's respiratory cycle and to fix the trunk of the body of patient during radiation therapy.
This Air-Bag System can properly press the abdomen and stabilize patient's positioning repeatability easily in continuous radiation therapy.
Not Found
This is a 510(k) premarket notification for an "Air-Bag System" intended to monitor a patient's respiratory cycle and fix the trunk during radiation therapy. It is not an AI/ML powered device, therefore no information about acceptance criteria and studies are provided.
§ 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.