(90 days)
The EXL series of accelerators are intended to be used for electron or photon radiation treatment of cancer.
Medical Linear Accelerators provide a high energy beam of electrons and/or x-rays which is used for the treatment of cancer. The beam produced by the machine is carefully controlled in terms of geometry, energy, uniformity and intensity. The device also provides mechanisms for positioning the patient and controlling the delivery geometry.
The accelerators consist of three major subsytems, the Control Console. Gantry Stand, and Rotating Gantry.
The control console is the main component for operation and control of the LINAC. It is used to select the machine operation and patient treatment parameters and monitor the machine operating conditions. The new control console for the EXL-DP series of accelerators consists of an operator keyboard, video display, and various computers and control circuits.
The Gantry Stand contains the high power sources for the accelerator system, notably the Klystron microwave power, modulator and electromagnet power supplies,
The Rotating Gantry contains the accelerating tube, energy switching system, beam bending magnet, x-ray target, collimator, dosimetry system, and various safety features and circuits.
The provided text is a 510(k) summary for a medical device (linear accelerator) and does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The document describes a modification to an existing device (replacement of a hard-wired control console with a computerized one) and asserts that there is "no change in the function or performance specifications or characteristics" of the device after this modification.
Therefore, I cannot 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.