Eclipse II with Smart Noise Cancellation
Carestream Health, Inc.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.
Intended Use
The software performs digital enhancement of a radiographic image generated by an x-ray device. The software can be used to process adult and pediatric x-ray images. This excludes mammography applications.
Technology
Eclipse II with Smart Noise Cancellation is an image processing software that uses a convolutional neural network (CNN) to perform advanced noise reduction on digital radiography images prior to the typical image enhancement processing. It processes images from Computed Radiography (CR) and Direct Radiography (DR) detectors, improving image quality by suppressing noise while maintaining diagnostic features.
Performance
Non-clinical testing included analysis of difference images and ideal observer evaluation with simulated lesions, confirming preserved or improved detectability and absence of residual image artifacts. Clinical evaluation by radiologists showed improved diagnostic image quality across a range of exam types and exposure levels. The modifications demonstrated no new safety or effectiveness concerns compared to the predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/26/2020
7 months - 2
FDA Approval
4/2/2021
Other devices from Carestream Health, Inc.
- Eclipse II with Smart Noise Cancellation2022 • 510K
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