# K141741: Aquilion Prime, V6.00

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Nov 26, 2014 after 152 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K120710 (2012). 2 ancestors in all.
18 later devices descend from it; 4 cite 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)
- K130645: Aquilion Prime, V5.00, Toshibamedical Systems Corporation (2013) Summary page 5.

## Most influential descendants
- 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
- K182901: Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE (2019), 3 descendants of its own

## Recalls of this device
- Oct 25, 2016 · Class II · Z-0622-2017: Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.
- May 8, 2015 · Class II · Z-0018-2016: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

## 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/K141741
Methodology: https://510kreport.com/methodology