# K072606: Aquilion One TSX-301A/2 Computed Tomography System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 2, 2007 after 15 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063189 (2006). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063189: TSX-301A, Aquilion One CT System, Toshiba America Medical Systems, In.C (2006) Summary page 1.

## Most influential descendants
- K083282: Model TSX-301B Aquilion CT System (2008), 1 descendant of its own
- K120546: Aquilion Premium (2012), 0 descendants of its own

## Recalls of this device
- Jun 22, 2011 · Not classified · Z-3196-2011: Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, 
- Jul 13, 2009 · Class II · Z-2282-2012: 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and recons
- Feb 3, 2009 · Not classified · Z-2339-2010: ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.
- May 13, 2008 · Class II · Z-2468-2012: The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.

## Indications for use
This device is indicated to 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 then 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/K072606
Methodology: https://510kreport.com/methodology