# K134025: Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CT

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Sep 5, 2014 after 249 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: 8 generations back to K890348 (1989). 28 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111633: Aquilion LB Movement Base Kit, Toshiba America Medical Systems, In.C (2011) Summary page 5.
- K122109: Aquilion One Vision, V4.90, Toshiba America Medical Systems, In.C (2012) Summary page 5.
- K113052: Infinix-Cci, Toshiba America Medical Systems, In.C (2011) Summary page 5.

## Most influential descendants
- K143223: CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT (2015), 2 descendants of its own
- K182223: Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A (2018), 1 descendant of its own
- K251645: Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP (2025), 0 descendants of its own

## Indications for use
Optional movable gantry base unit for use with an Aquilion ONE (TSX-301C) system to support longitudinal movement and allow acquisition of images in the z-direction (Z-axis). Note: When installed with the movable gantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room.

Source page: https://510kreport.com/device/K134025
Methodology: https://510kreport.com/methodology