# K173468: Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Feb 23, 2018 after 107 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: 3 generations back to K120710 (2012). 3 ancestors in all.
4 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)
- K141741: Aquilion Prime, V6.00, Toshibamedical Systems Corporation (2014) Summary page 5.

## Most influential descendants
- K182901: Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE (2019), 3 descendants of its own
- 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

## Recalls of this device
- Mar 25, 2019 · Class II · Z-1725-2020: 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. 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 gqualified 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.

Source page: https://510kreport.com/device/K173468
Methodology: https://510kreport.com/methodology