Author: Eugene Cho, MD
Canon Medical Systems USA received 510(k) FDA clearance for its Advanced Intelligent Clear-IQ Engine on October 21, 2019 and clearance for three computed tomography models and one magnetic resonance imaging model using the technology, Aquilon One on 6/12/2019, Aquilon Precision on 7/5/2019, Aquilon Prime on 2/21/2020 and Vantage Galan 3T MR3020 v6 on 3/9/2020.
The Advanced Intelligent Clear-IQ Engine (AiCE) is a Deep Learning Reconstruction technology that harnesses the power of artificial intelligence to improve the resolution and anatomical detail of images. AiCE uses artificial intelligence nodes called “neurons” networked in a fashion mimicking human neuron connections in multiple layers to create and follow self-modifying algorithms that can be trained using analysis of sample data sets to meet or exceed human capacity to accurately differentiate images. In combination with ultra-high resolution computed tomography platforms the engine is trained at the factory using sample data sets containing both high and low quality input data compared to a gold standard image which allows the system to differentiate signal from noise and render ultra-high resolution images with superior signal-to-noise ratio using the same radiation dose as conventional scan technology. This can be achieved 3-5 times faster than the previous generation Model Based Iterative Reconstruction (MIBR).
The FDA found that all four models were substantially equivalent to predicate devices, performing in a similar manner to and intended for the same use as the predicate devices as indicated in product labeling.
The devices are indicated to acquire and display cross-sectional volumes of the whole body, to include the head, using indicated software/hardware by a trained and qualified physician.
Enhanced anatomical detail
AiCE is trained to increase the signal-to-noise ratio