(81 days)
The Therapax SXT 150 is a variable low energy x-ray system intended for superficial cases and lesions. Typical applications include radiotherapy treatments of cancerous tumors and research. Typical treatments include treatment for basal cell carcinoma, squamous cell carcinoma, Karpos's Sarcoma, rectal adenocarcinoma and other intracavital sites.
variable low energy x-ray system
This is a letter acknowledging the receipt and review of a 510(k) premarket notification for the "Therapax SXT 150 X-Ray Therapy Device." This document itself does not contain any information about acceptance criteria or a study proving device performance against such criteria. It is a regulatory approval letter based on the device being substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from the given text.
To address your request, I would need a different document, such as a 510(k) summary, a clinical study report, or a technical specification document that describes the device's performance characteristics and the studies conducted to establish them.
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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.