ALLURA XPER FD20

• K Number: K033737
• Device Name: ALLURA XPER FD20
• Manufacturer: PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
• Date Cleared: 2003-12-09 ( 11 days)
• Product Code: OWB , IZI , JAA
• Regulation Number: 892.1650
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K002016

Intended Use

The Allura Xper FD20 is intended for:

• · Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, " e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolyses.
• · Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP),
• Non-vascular interventions such as drainages, biopsies and . vertebroplasties procedures.

Device Description

The Allura Xper FD20 is a stationary fluoroscopic angiographic X-ray system for vascular, neurovascular and cardiovascular procedures, as well as non-vascular procedures.

AI/ML Overview

The provided text is a 510(k) summary for the Philips Allura Xper FD20, an X-ray system. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for AI/algorithm performance.

Therefore, I cannot fulfill your request as the required information is not present in the provided document.

The document primarily focuses on:

• Device Identification: Company name, device name (Allura Xper FD20), classification names.
• Predicate Device: Philips Integris Allura (K002016).
• Device Description: Stationary fluoroscopic angiographic X-ray system for vascular, neurovascular, cardiovascular, and non-vascular procedures.
• Intended Use: Specific applications like angiography, PTCA, stent placements, embolizations, thrombolysis, pacemaker implantations, and non-vascular interventions.
• Safety and Effectiveness: Compliance with regulatory standards (e.g., 21CFR, UL 2601-1, DICOM).
• Conclusion: The device is substantially equivalent to the predicate and introduces no new hazards or indications.

This is a typical 510(k) submission for an imaging hardware device, not an AI or algorithm-based software device, and therefore does not include the types of performance metrics and study details you've requested.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.