(97 days)
The AIO Breast and Lung Board Solution is a positioning and immobilization system to set-up and reproduce the supine position of a breast or lung patient during radiation.
The AIO Head and Neck Solution is indicated to aid in supporting the knees or ankles of patients undergoing radiation therapy in the supine or prone position. The device is also used during image acquisition to support treatment planning.
Not Found
The provided text is a 510(k) premarket notification letter for a medical device (The AIO Solution) and its Indications for Use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot provide the requested information based on the input text. The letter primarily states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
§ 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.