Philips Receives U.S. FDA 510(k) Clearance to Market ProxiDiagnost N90, its Premium Digital Radiography and Nearby Fluoroscopy System

Royal Philips, a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market ProxiDiagnost N90, its newest premium Digital Radiography-Fluoroscopy (DRF) system. With its ability to perform both nearby fluoroscopy and digital X-rays through a single system, ProxiDiagnost N90 supports high room utilization and increased patient throughput, while also providing outstanding workflow support and patient accessibility.

• Enhanced image quality – The ProxiDiagnost N90 provides high-quality images with premium flat detector technology and the new dynamic UNIQUE image processing, thanks to which sequences are stable and harmonized from the first frame to the end. This eliminates the need for several frames to produce a usable image and make a confident diagnosis.
• Support for staff workflow – With support for nearby use, ProxiDiagnost N90 allows technologists to conduct procedures next to the patient, in keeping with common workflow and to improve the patient experience. The system also features the Philips Eleva user interface, allowing clinicians familiar with the design to use the system immediately without additional training due to Philips’ platform approach for the design of its premium portfolio.
• Greater patient accessibility – Thoughtful design, including a small footprint and an open overhead area and table, enables technologists or caregivers to be closer to the patient during procedures. This is especially important for pediatric and elderly patients, or others who may need additional support to remain calm during the procedure.
• For pediatric examinations – Philips’ Grid-Controlled Fluoroscopy (GCF) enables a dose rate reduction up to 68%¹compared to Pulse Controlled Fluoroscopy (PCF), depending on the patient type and clinical application.

“As a dual-use system, ProxiDiagnost N90 meets key dimensions of healthcare’s Quadruple Aim and is a smart choice for healthcare organizations that need a new fluoroscopy solution – particularly those in the U.S. that follow a nearby use method,” said Sandra Burghardt, Senior Director of Global Marketing for Diagnostic X-ray at Philips. “We are setting the bar higher and enabling a confident diagnosis from the first frame. ProxiDiagnost N90 gives radiologists and technologists the ability to capture high-quality still or video images in a way that aligns with their workflow and provides an improved patient experience.”