# K130645: Aquilion Prime, V5.00

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jun 6, 2013 after 87 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 K120710 (2012). 1 ancestor in all.
19 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120710: Aquilion Prime, Toshibamedical Systems Corporation (2012) Summary page 1.

## Most influential descendants
- K141741: Aquilion Prime, V6.00 (2014), 18 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
- K173468: Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 (2018), 4 descendants of its own
- K222819: Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (2023), 3 descendants of its own

## 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/K130645
Methodology: https://510kreport.com/methodology