(91 days)
The Raycast MammoRx Carbon Fibre Breast Board is a positioning and immobilization system to set-up and reproduce the supine position of a breast patient during radiation therapy.
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This document is a 510(k) premarket notification decision letter from the FDA for the "Raycast MammoRx Carbon Fibre Breast Board." It informs the manufacturer that their device has been found substantially equivalent to a predicate device.
This document does not contain information about the acceptance criteria and study results for the device's performance.
The provided text focuses on the regulatory approval process (510(k)), classification of the device, applicable regulations, and administrative details. It includes the device name, its intended use (positioning and immobilization for breast radiation therapy), and the 510(k) number (K162355).
Therefore, I cannot provide the requested information from this document. To answer your query, a different document, such as the actual 510(k) submission or a performance study report, would be necessary.
§ 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.