(164 days)
For radiation therapy, patient/body contouring, virtual simulation and verification of the patient's treatment plan. Provides any simulator with a fast, non-contact method for obtaining accurate patient contours. The results can be downloaded to the treatment planning computer. Profa is fully automatic and offers software solution for scanning and simulation of the breast, pelvis, head and neck, treatment masks and sagittal cases. The hand-held Profa plus system is portable and can be used in the radiotherapy room.
PROFA an Optical Patient Contouring Device
The provided text is a 510(k) clearance letter from the FDA for the PROFA an Optical Patient Contouring Device. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter is a regulatory approval document and not a technical summary of the device's validation. Therefore, it is impossible to extract the requested information from the provided 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.