# K110066: Aquilion Prime

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jan 26, 2012 after 381 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: 1 generation back to K093891 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion PRIME 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/K110066
Methodology: https://510kreport.com/methodology