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Intended Use

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include, but are not limited to brain, heart, pancreas, etc. The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

Technology

The device is a whole body multi-slice helical CT scanner incorporating the AiCE algorithm, a noise reduction AI technique using Deep Convolutional Neural Network methods that improve image quality by differentiating structure from noise. It features iterative reconstruction technology and typical CT scanner hardware components (gantry, couch, console).

Performance

Performance testing included phantom studies measuring contrast-to-noise ratios, noise power spectra, low contrast detectability, and spatial resolution. These studies demonstrated that AiCE reduces image noise by approximately 29.2%, improves low contrast detectability by 12.2%, and achieves a dose reduction of ~80%. Radiologist image review confirmed diagnostic image quality. Testing was conducted under applicable IEC standards and FDA guidance for software and cybersecurity.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/2/2018

    7 months
  • 2

    FDA Approval

    6/12/2019

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