MaxFOV 2
GE Medical Systems, LLC.MaxFOV 2 is a software option for GE CT scanners that uses deep learning to extend the display field of view in CT images beyond the scanner's nominal field, providing improved visualization of patient anatomy, especially useful in radiation therapy planning and for large patients. This helps clinicians obtain more complete images for diagnosis and treatment planning when parts of the body are outside standard scan coverage.
Intended Use
The deep learning based Max Field-of-View (MaxFOV 2) is a CT image reconstruction method intended to produce images of the head and whole-body using Axial, Helical, and Cine acquisitions.
Technology
MaxFOV 2 applies a deep learning (CNN) algorithm to extend the CT display field of view (DFOV) beyond the scan field of view (SFOV), allowing visualization up to 80 cm. The software works across multiple GE CT scanner platforms and does not require hardware changes, improving upon the predicate Wide View option by using deep learning.
Performance
Extensive non-clinical (bench) tests using phantoms evaluated skin contour accuracy, CT number accuracy, and image quality on multiple GE CT systems, demonstrating consistent and acceptable performance. Clinical testing included a reader study of 49 CT exams scored by five external radiologists for depiction of skin surface, tissue density, and image quality, supporting substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/11/2020
2 months - 2
FDA Approval
3/2/2021
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