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Intended Use

Acquire and display cross sectional volumes of the whole body including head and organs with capability for specialized studies. Uses iterative reconstruction and deep convolutional neural networks for noise reduction and spatial resolution enhancement in abdomen, pelvis, chest, cardiac, extremities, and head.

Technology

A whole body multi-slice helical CT scanner with gantry, couch, and console for data processing. Equipped with PIQE, a deep learning reconstruction technology using a Deep Convolutional Neural Network (DCNN) to enhance spatial resolution and reduce noise, outperforming FBP and hybrid iterative reconstructions. Also includes spectral imaging and other iterative reconstruction algorithms like FIRST and AiCE for noise reduction and image quality improvements.

Performance

Bench testing with phantoms showed that the Aquilion ONE with PIQE provides equivalent or improved image quality compared to the predicate device across contrast-to-noise ratio, uniformity, low contrast detectability, and spatial resolution. Dose reduction achieved with specialized filters. Clinical images reviewed by certified radiologists confirmed diagnostic image quality. Software validation and risk analysis support safety and effectiveness.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    9/14/2023

    6 months
  • 2

    FDA Approval

    4/2/2024

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