(30 days)
The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
PortalVision has been modified to add a kilovoltage xray source and digital imaging system to allow for improved image quality. This additional option will be called the On-Board Imager device and its intended use will be to supplement the PortalVision device or be used as a stand-alone device to allow for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation anatomical and/or fiducial landmarks.
The provided text is a 510(k) summary for the Varian Medical Systems On-Board Imager, a device intended to verify patient position and treatment fields in relation to anatomical or fiducial landmarks during radiation therapy.
However, the provided document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The text describes the device, its intended use, and its substantial equivalence to predicate devices but omits details about performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested table or answer the specific questions based on the information given. The document focuses on regulatory approval based on substantial equivalence rather than detailed performance study results.
§ 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.