# K080211: Model TSX-101A/H/I Aquilion 32/64 SP CT System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Mar 14, 2008 after 45 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). 3 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K101888: Scenaria Whole-Body X-Ray CT System (2011), 15 descendants of its own
- K123509: Scenaria Phase 2 Whole-Body X-Ray CT System (2013), 14 descendants of its own
- K161748: SUPRIA w/guideShot Option (2016), 11 descendants of its own
- K163528: HITACHI Supria Whole-body X-ray CT System Phase 3 (2017), 10 descendants of its own
- K171738: Supria True64 (2017), 9 descendants of its own

## Recalls of this device
- May 8, 2015 · Class II · Z-0013-2016: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
- Oct 1, 2013 · Class II · Z-1113-2014: Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray
- Dec 8, 2010 · Not classified · Z-3221-2011: There is the potential that the current may not be controlled correctly in examinations using the ECG modulation function, which adjusts the x-ray output in synchronization with the ECG waveform.
- Apr 9, 2010 · Not classified · Z-2204-2011: The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (
- Jan 8, 2009 · Not classified · Z-1168-2010: Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helica
- Jan 8, 2009 · Not classified · Z-1166-2010: Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helica
- Jan 8, 2009 · Not classified · Z-1167-2010: Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helica
- Jan 8, 2009 · Not classified · Z-1169-2010: Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helica

## 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/K080211
Methodology: https://510kreport.com/methodology