(65 days)
The Philips Integris Series Release 2 systems are intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications.
The Philips Integris Series Release 2 systems include the Integris H5000, BH5000, V5000, BV5000, and HM2000. These systems are fully integrated, single and biplane, cath labs.
The provided text describes a 510(k) summary for the Philips Integris Series Release 2 systems, an angiographic X-ray system. This document outlines the intended use and system description, but does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot populate the requested table or sections. The document focuses on regulatory approval and safety/software information, not clinical performance studies against specific acceptance criteria.
§ 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.