# K151833: Aquilion Lightning (TSX-035A/2, V7.0)

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Oct 9, 2015 after 95 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: 2 generations back to K093891 (2010). 2 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121553: Aquilion RXL, Toshibamedical Systems Corporation (2012) Summary page 5.

## Most influential descendants
- 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
- K172188: Aquilion Prime SP, TSX-303B/1, v8.4 (2017), 3 descendants of its own

## Recalls of this device
- Apr 12, 2016 · Class II · Z-1560-2016: Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.

## Indications for use
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning 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/K151833
Methodology: https://510kreport.com/methodology