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.
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.
The software uses a Convolutional Neural Network (CNN) trained on clinical images with added simulated noise to reduce noise in digital radiography images prior to enhancement processing. It is integrated as an optional module within the Eclipse II software and supports both Computed Radiography (CR) and Digital Radiography (DR) detectors from Carestream. The noise suppression is implemented via a CNN based on a U-Net architecture generating a noise field map for noise reduction.
Clinical testing involved board-certified radiologists evaluating images processed with the software using visual difference preference scales and RadLex scales. Results demonstrated diagnostic quality images at 50% dose reduction for CsI panel images and 40% dose reduction for GOS panel images, with image quality equivalent to or better than nominal dose images over various exams, detector types, and exposures.
No predicate devices specified
Submission
10/4/2021
FDA Approval
1/14/2022
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