(16 days)
To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "TN-RD-60 Patient Dose Verification System" (later referred to as "MOSFET AutoSense Patient Dose Verification System"). This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.
The document does not contain specific acceptance criteria or details of a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which is not provided here. The clearance letter only confirms that the FDA has reviewed the submission and made a substantial equivalence determination based on the provided information.
Therefore, I cannot provide the requested information from the 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.