(90 days)
The Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. Specifically, they can be use in intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas. Additionally, they can be used in the body for treating hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, prostatic and breast tumors.
Not Found
I am sorry, but based on the provided document, I cannot answer the question regarding the acceptance criteria and the study that proves the device meets them. This document is a 510(k) clearance letter from the FDA for "Fiducial Markers" and primarily focuses on the device's substantial equivalence to a predicate device and its indications for use. It does not contain information about specific acceptance criteria or the details of a study demonstrating performance against such criteria.
§ 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.