(46 days)
The Avanza patient positioning table is used as a universal patient support to accurately and reproducibly position patients for radiation therapy and simulation. The Avanza is used with THERATRON® Equinox™ units and is also adaptable to third party radiation therapy treatment devices.
The Avanza Patient Positioning Table is a powered radiation therapy patient support assembly that is substantially equivalent in functionality and performance as the previously cleared Precise Treatment Table.
The Avanza Patient Positioning Table is supported by a mechanism and features several functions including isocentric rotation, column rotation, longitudinal, lateral, and vertical motions. The computer-controlled table can be activated by using the table mounted control panels or by using an optional hand control.
This K060870 510(k) submission describes the Avanza Patient Positioning Table, a device used to position patients for radiation therapy. The submission focuses on demonstrating substantial equivalence to a predicate device, the Precise Treatment Table (K983678). There is no information provided about acceptance criteria or a study demonstrating the device meets those criteria in the provided text.
Therefore, I cannot fulfill the request as the essential information for acceptance criteria and study details is missing from the provided document. The document primarily identifies the device, its intended use, and its substantial equivalence to a predicate device, which is a regulatory filing, not an performance evaluation study.
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.