# K121553: Aquilion RXL

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jul 26, 2012 after 62 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: 1 generation back to K093891 (2010). 1 ancestor in all.
13 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093891: Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2, Toshibamedical Systems Corporation (2010) Summary page 1.

## Most influential descendants
- 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
- K222819: Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (2023), 3 descendants of its own

## Recalls of this device
- Oct 1, 2013 · Class II · Z-1113-2014: Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray

## Indications for use
This device is indicated to a acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion RXL 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.

Source page: https://510kreport.com/device/K121553
Methodology: https://510kreport.com/methodology