# K991766: Ecg-Gating System for Aquilion CT Scanner, TSX-101A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Aug 10, 1999 after 78 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903701 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982265: Aquilion CT Scanner, Model TSX-101A, Toshiba America Medical Systems, In.C (1998) Summary page 1.
- K990134: Multislice Upgrade Kit for Aquilion CT Scanner, TSX-101A (Aquilion,Multi), Toshiba America Medical Systems, In.C (1999) Summary page 1.

## Most influential descendants
- K160350: ECG CT Gating Device (2016), 0 descendants of its own

## Indications for use
This device is indicated to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. This specific model employs the use of ECG signals to specify the timing of the x-ray transmission commencement.

Source page: https://510kreport.com/device/K991766
Methodology: https://510kreport.com/methodology