# K033418: TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 10, 2003 after 14 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031469 (2003). 1 ancestor in all.
25 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031469: Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7, Toshiba America Medical Systems, In.C (2003) Summary page 1.
- (no number) TSX-101N8 Aquilion 16 CT: named in the summary without a submission number
- (no number) TSXC-101A/8 CT System: named in the summary without a submission number

## Most influential descendants
- K051833: TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner (2005), 24 descendants of its own
- K080211: Model TSX-101A/H/I Aquilion 32/64 SP CT System (2008), 17 descendants of its own
- 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

## Recalls of this device
- Jan 8, 2009 · Not classified · Z-1164-2010: 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-1165-2010: 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
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

Source page: https://510kreport.com/device/K033418
Methodology: https://510kreport.com/methodology