Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

Canon Medical Systems Corporation

510k7/5/2019

FDA #

K182901

Product Code

JAK

Panel

Radiology

Modality:CT Task:Reconstruction Body Region:Whole Body

The Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is an advanced CT scanner that captures high-resolution 3D images of the whole body. It uses an AI-based algorithm called AiCE (Advanced intelligent Clear-IQ Engine) to reduce image noise and enhance image quality, which helps clinicians detect details more clearly. This makes diagnoses more accurate and can potentially reduce patient radiation exposure.

Intended Use

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Precision has the capability to provide volume sets for specialized studies using indicated software/hardware by qualified physicians.

Technology

A multi-slice helical CT scanner with a 160-row detector and advanced reconstruction technology called AiCE, which uses deep convolutional neural network methods to reduce image noise and improve image quality, producing fast, high-quality CT reconstructions at 1024x1024 resolution.

Performance

Performance testing demonstrates 13% improved low contrast detectability and 42% noise reduction compared to prior algorithms, with dose neutrality maintained. Testing involved phantom image quality metrics and radiologist review confirming diagnostic image quality.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

1
Submission
10/16/2018
8 months
2
FDA Approval
7/5/2019

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