# K113466: Aquilion One

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba Medical Systems Coporation, Japan
- Decided: Apr 10, 2012 after 140 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
47 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K122109: Aquilion One Vision, V4.90 (2012), 41 descendants of its own
- K132222: Aquilion One Vision, V6.0 (2013), 31 descendants of its own
- K133497: Aquilion One Vision (2014), 23 descendants of its own
- K142465: Aquilion ONE Vision, v7.0 (2015), 22 descendants of its own
- K151673: Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) (2015), 13 descendants of its own

## Recalls of this device
- May 8, 2015 · Class II · Z-0014-2016: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
- Nov 5, 2014 · Class II · Z-0472-2015: Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CF
- Oct 1, 2013 · Class II · Z-1113-2014: Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray

Source page: https://510kreport.com/device/K113466
Methodology: https://510kreport.com/methodology