# K192188: Aquilion ONE (TSX-306A/3) V10.0

- Pathway: 510(k) (Special)
- Applicant: Canon Medical Systems Corporation
- Decided: Sep 6, 2019 after 24 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: 9 generations back to K113466 (2012). 10 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183046: Aquilion ONE (TSX-305A/6) V8.9 with AiCE, Canon Medical Systems Corporation (2019) Summary page 5.

## Most influential descendants
- K192828: Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System (2020), 8 descendants of its own
- K203225: Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System (2021), 7 descendants of its own
- K213504: Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A (2022), 6 descendants of its own
- K232835: Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System (2024), 3 descendants of its own
- K242403: Aquilion ONE (TSX-308A/3) V1.5 (2024), 2 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.

Source page: https://510kreport.com/device/K192188
Methodology: https://510kreport.com/methodology