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.

Eclipse II with Smart Noise Cancellation is a software module integrated within the Carestream ImageView application that enhances digital radiography images by reducing noise using a Convolutional Neural Network. It supports various Carestream digital radiography detectors. This technology allows for up to 50% dose reduction in certain detector types without sacrificing image quality, helping clinicians obtain clearer x-ray images at lower radiation doses, thus improving patient safety and diagnostic confidence.

FDA #
K213307
Product Code
MQB

Eclipse II with Smart Noise Cancellation is software that improves digital X-ray images by reducing noise using advanced AI technology. It enhances images acquired with digital radiography systems, helping radiologists see clearer images for better diagnosis of adult and pediatric patients, excluding mammography.

FDA #
K202441
Product Code
MQB
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