# K232835: Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Apr 2, 2024 after 201 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K913770 (1991). 189 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213504: Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A, Canon Medical Systems Corporation (2022) Summary page 5.

## Most influential descendants
- K242403: Aquilion ONE (TSX-308A/3) V1.5 (2024), 2 descendants of its own
- K253596: Aquilion ONE (TSX-308A/TSX-306A) V2.0 (2026), 0 descendants of its own
- K251645: Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP (2025), 0 descendants of its own

## Indications for 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. FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications. AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, brain, extremities, head, and inner ear applications. The spectral imaging system allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The X-ray dose will be the sum of the dose at each respective tube voltage and current in a rotation. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies. When used by a qualified physician, a potential application is to determine the course of treatment. PIQE is a Deep Learning Reconstruction method designed to enhance spatial resolution. By incorporating noise reduction into the Deep Convolutional Neural Network (DCNN), it is possible to achieve both spatial resolution improvement and noise reduction for cardiac, abdomen, and pelvis applications, in comparison to FBP and hybrid iterative reconstruction..

Source page: https://510kreport.com/device/K232835
Methodology: https://510kreport.com/methodology