# K150003: Aquilion LB, TSX-201A/3, V6.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Mar 19, 2015 after 76 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K903701 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123500: Aquilion LB Triton V4.91, Toshibamedical Systems Corporation (2013) Summary page 5.

## Indications for use
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion 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/K150003
Methodology: https://510kreport.com/methodology