(30 days)
Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.
Leksell GammaPlan® is a computer-based dose planning system specifically designed for Eeksell Gamma Knife®. Leksell Gamma Plan® is intended to be used for alse with the Losiments, in stereotactic radiosurgery and stereotactic radiotherapy.
I am sorry, but the provided text does not contain the information needed to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) summary and approval letter, which primarily focuses on substantial equivalence to predicate devices and regulatory classification. It does not detail specific performance studies, acceptance criteria, or the methodology used to validate the device's performance.
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.