(52 days)
This device is an angiographic X-ray system, as described in 21 CFR 892.1600. This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positin ing device and other devices.
This device is an angiographic X-ray system, as described in 21 CFR 892.1600.
This document is a 510(k) clearance letter from the FDA for the BRANSIST Safire angiographic X-ray system. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The letter primarily addresses the device's substantial equivalence to predicate devices, its regulatory classification, and general marketing requirements. It does not include performance data, study designs, sample sizes, expert qualifications, or ground truth information.
Therefore, I cannot provide the requested information from the provided text.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.