Intelligent NR
Canon Inc.Intelligent NR is a software function integrated with Canon's CXDI Control Software that uses machine learning-based noise reduction to enhance the quality of digital X-ray images. It helps clinicians obtain clearer images from conventional radiographic exams, improving diagnostic confidence especially in trauma, intensive care, and pediatric settings.
Intended Use
As a part of the Canon radiography system, the CXDI Control Software when used with a compatible Canon detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.
Technology
The Intelligent NR function is part of the CXDI Control Software version 3.10, developed using machine learning trained on an existing clinical image database to learn noise characteristics and reduce noise in X-ray images. It operates on a PC in conjunction with cleared Canon detectors and does not perform further machine learning after release. The software controls image capture, GUI display, and processing.
Performance
Performance testing confirmed no modifications to the Canon Digital Radiography detectors hardware, retaining safety and effectiveness equivalent to predicate devices. Risk analysis using FMEA ensured identified hazards were mitigated. Compatible detectors comply with US radiographic equipment performance standards and relevant IEC electrical and electromagnetic safety standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/20/2021
1 month - 2
FDA Approval
9/17/2021
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