# K083282: Model TSX-301B Aquilion CT System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Dec 12, 2008 after 35 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K031469 (2003). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072606: Aquilion One TSX-301A/2 Computed Tomography System, Toshiba America Medical Systems, In.C (2007) Summary page 1.
- K051833: TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner, Toshiba America Medical Systems, In.C (2005)

## Most influential descendants
- K120546: Aquilion Premium (2012), 0 descendants of its own

## Recalls of this device
- Jan 3, 2012 · Not classified · Z-1034-2012: The recall was initiated because Toshiba has confirmed that their is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One.
- Jan 3, 2012 · Not classified · Z-1035-2012: The recall was initiated because Toshiba has confirmed that their is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One.
- Jun 22, 2011 · Not classified · Z-3195-2011: 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, 
- Jan 7, 2011 · Not classified · Z-2895-2011: Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the s
- Jan 7, 2011 · Not classified · Z-2896-2011: Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the s
- Sep 7, 2010 · Not classified · Z-1257-2011: Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. This results in a pre-scan expe
- Jul 22, 2010 · Not classified · Z-1665-2011: Toshiba America Medical Systems (TAMS) has found that communication may be cut off in the Aquilion ONE/ Premium Systems, owing to the failure of a part used in the console.
- Jan 7, 2010 · Not classified · Z-0907-2010: When W-Volume is performed in Prospective CTA or Target CTA studies with ECG gating, unnecessary intervals may be set before starting the volume scan. As a result, scanning cannot be performed at the 

## Indications for use
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

Source page: https://510kreport.com/device/K083282
Methodology: https://510kreport.com/methodology