(10 days)
The Allura Xper FD10 is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.
The Allura Xper FD10 is a stationary angiographic X-ray imaging system with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. The monoplane system can be configured as either a floor or a ceiling suspended G-arm frontal stand.
This document is a 510(k) premarket notification for the Philips Allura Xper FD10, an angiographic X-ray system. It establishes substantial equivalence to a predicate device and does not contain acceptance criteria or a study proving the device meets them. It's a regulatory submission, not a performance study report.
Therefore, I cannot provide the requested information from the provided text, as the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample size, data provenance, number of experts, adjudication methods, or ground truth for test sets.
- Information about MRMC effectiveness studies or standalone algorithm performance.
- Details about training set size or how its ground truth was established.
This document focuses on regulatory compliance and substantial equivalence, not on the detailed performance validation of an AI/ML device.
§ 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.