# K093891: Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2

- Pathway: 510(k) (Abbreviated)
- Applicant: Toshibamedical Systems Corporation
- Decided: Nov 18, 2010 after 335 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
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K121553: Aquilion RXL (2012), 13 descendants of its own
- K151833: Aquilion Lightning (TSX-035A/2, V7.0) (2015), 11 descendants of its own
- K153263: Aquilion Lightning, TSX-035A/4 and /5, V7.0 (2016), 10 descendants of its own
- K170019: Aquilion Lightning, TSX-036A/1, V8.4 (2017), 9 descendants of its own
- K201836: Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i (2021), 4 descendants of its own

## Recalls of this device
- Mar 25, 2019 · Class II · Z-1720-2020: 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 of imaging 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 then be used to perform specialized studies, using indicated software/hardware of the whole organ by a trained and qualified physician. The Dual Energy System has been designed to analyze the composition of body materials. The system can load two CT images scanned with two different tube voltages and analyze the composition of the target materials by using the energy dependence of the attenuation coefficients of materials.

Source page: https://510kreport.com/device/K093891
Methodology: https://510kreport.com/methodology