# K182901: Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Jul 5, 2019 after 262 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: 4 generations back to K120710 (2012). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173468: Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0, Toshibamedical Systems Corporation (2018) Summary page 5.

## Most influential descendants
- K220986: Aquilion Precision (TSX-304A/4) V10.10 with AiCE (2022), 2 descendants of its own
- K223726: Aquilion Precision (TSX-304A/4) V10.14 with AiCE (2023), 1 descendant of its own
- K243398: CT Scanner TSX-501R/1 V11.1 (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. The Aquilion Precision 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. FIRST 3.0 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 and pelvis applications.

Source page: https://510kreport.com/device/K182901
Methodology: https://510kreport.com/methodology