# K170177: Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jun 30, 2017 after 162 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K113466 (2012). 8 ancestors in all.
11 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)
- K160587: Aquilion ONE (TSX-305A/3) V7.3, Toshibamedical Systems Corporation (2016) Summary page 5.
- K161009: Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4, Toshibamedical Systems Corporation (2016) Summary page 5.

## Most influential descendants
- K183046: Aquilion ONE (TSX-305A/6) V8.9 with AiCE (2019), 10 descendants of its own
- K192188: Aquilion ONE (TSX-306A/3) V10.0 (2019), 9 descendants of its own
- 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

## Recalls of this device
- Mar 25, 2019 · Class II · Z-1726-2020: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot.

## 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 2.1 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.

Source page: https://510kreport.com/device/K170177
Methodology: https://510kreport.com/methodology