# K982265: Aquilion CT Scanner, Model TSX-101A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Aug 26, 1998 after 58 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903701 (1990). 1 ancestor in all.
19 later devices descend from it; 3 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)
- K903701: Xpress, Toshiba America Medical Systems, In.C (1990) Summary page 1.

## Most influential descendants
- K020385: CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A (2002), 15 descendants of its own
- K022050: CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion Advance Multi) (2002), 14 descendants of its own
- K050458: TSX-201A Aquilion LB CT Scanner (2005), 12 descendants of its own
- K123500: Aquilion LB Triton V4.91 (2013), 4 descendants of its own
- K111633: Aquilion LB Movement Base Kit (2011), 4 descendants of its own

## Recalls of this device
- Oct 1, 2007 · Not classified · Z-1708-2008: Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.
- Oct 1, 2007 · Not classified · Z-1707-2008: Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.
- Mar 17, 2004 · Not classified · Z-1031-04: Erroneous patient data is entered. Previoius patient's demographics are recorded.

## Indications for use
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

Source page: https://510kreport.com/device/K982265
Methodology: https://510kreport.com/methodology