FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

This product is a family of Philips MRI systems designed to produce detailed images of the body's internal structures. These MRI machines help doctors and clinicians by providing high-quality images that assist in diagnosing a variety of medical conditions across different body regions without using ionizing radiation.

FDA #
K251808
Product Code
LNH

The dS Knee Coil 8ch 1.5T is an 8-channel phased array MRI coil designed for use with Philips 1.5T MRI systems to produce high-resolution diagnostic images of the knee. The coil's design improves signal-to-noise ratio and patient comfort, enabling accurate imaging of knee anatomy for clinical evaluation by trained physicians.

FDA #
K242879
Product Code

The dS Wrist Coil 8ch 1.5T is a specialized MRI coil designed to produce high-quality diagnostic images of the wrist. It improves image clarity by using an 8-channel phased-array design for better signal reception, helping physicians accurately evaluate wrist conditions through MRI scans.

FDA #
K243033
Product Code

The Ingenia series MR Systems by Philips Medical Systems Nederland B.V. are advanced MRI devices that produce detailed cross-sectional images and spectra of the head, body, and extremities. Utilizing strong magnetic fields and radio signals, these systems aid physicians in diagnosing diseases, planning treatments, and guiding minimally invasive procedures by providing high-quality images. The new Precise Image software feature enhances image quality by employing deep learning to improve sharpness and reduce noise and artifacts, facilitating better clinical assessment.

FDA #
K223458
Product Code
LNH

The Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems by Philips are advanced 1.5 and 3.0 Tesla MRI machines that produce high-quality cross-sectional images to help physicians diagnose various conditions. They include AI-enhanced features like SmartSpeed AI for faster image acquisition without loss of quality, aiding clinicians with quicker and improved diagnostic imaging.

FDA #
K213583
Product Code
LNH
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