# K063189: TSX-301A, Aquilion One CT System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 3, 2006 after 14 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
No predicates in its family tree.
67 later devices descend from it; 2 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TSX-IO1A/I Aquilion 64 SP CT System: named in the summary without a submission number

## Most influential descendants
- K081022: Somatom Definition, Model as/as+ (2008), 63 descendants of its own
- K103127: Somatom Definition as (2011), 53 descendants of its own
- K130901: Somatom Definition as Open (2014), 49 descendants of its own
- K082220: Somatom Flash DS (2008), 36 descendants of its own
- K143401: SOMATOM Definition Edge (2015), 35 descendants of its own

## Indications for use
Acquisition and display of axial x-ray images of the whole body to include the head.

Source page: https://510kreport.com/device/K063189
Methodology: https://510kreport.com/methodology