# K132222: Aquilion One Vision, V6.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Nov 7, 2013 after 113 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 K113466 (2012). 2 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122109: Aquilion One Vision, V4.90, Toshiba America Medical Systems, In.C (2012) Summary page 1.

## Most influential descendants
- 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
- K151091: Vitrea Software Toshiba Package, VSTP-001A (2015), 13 descendants of its own
- K171222: Vitrea Software Toshiba Package; VSTP-001A (2017), 12 descendants of its own

## Recalls of this device
- Nov 5, 2014 · Class II · Z-0471-2015: 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
- Dec 11, 2013 · Class II · Z-0972-2014: Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.

## Indications for use
This device is indicated ta acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc. The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

Source page: https://510kreport.com/device/K132222
Methodology: https://510kreport.com/methodology