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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. The Aquilion Serve has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

Technology

The system is a whole body multi-slice helical CT scanner capturing cross sectional volume data. AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that employs Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications to improve image quality and reduce noise.

Performance

Bench testing includes phantom studies for image quality and dose reduction, demonstrating improved or equivalent image quality compared to predicate. Workflow evaluation revealed reduced scan planning time with Anatomical Landmark Detection. Software verification and validation met requirements. The device meets applicable safety and radiation standards.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    5/3/2023

    4 months
  • 2

    FDA Approval

    9/19/2023

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