(196 days)
Computer aided planning of static and dynamic conformal radiation therapy treatments. The BrainSCAN Conformal RT Module is intended to plan radiation therapy treatments of lesions using conformal block collimators that are shaped (i.e. contour molded) to the outline of the lesion in beam's eye view or using a multileaf collimator. Using shaped collimators helps to deliver radiation exactly to the target volume while sparing surrounding healthy tissue and critical structures from accessing radiation.
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I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance of the BrainLab BrainScan Conformal RT Module. The document is an FDA 510(k) clearance letter from 1997, which confirms that the device is substantially equivalent to previously marketed devices for specific indications for use.
Therefore, I cannot provide the requested table and study details based on the given input.
§ 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.