# K061187: TSX-201A, Aquilion LB CT Scanner with Respiratory Gating

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: May 12, 2006 after 14 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: 5 generations back to K903701 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050458: TSX-201A Aquilion LB CT Scanner, Toshiba America Medical Systems, In.C (2005) Summary page 1.
- K983629: RPM Respiratory Gating System, Varian Medical Systems, Inc. (1999) Summary page 1.

## Indications for use
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy Respiratory (4D) Gated Scanning Respiratory Gated (4D) Scanning on the Aquilion LB is a non-invasive software/hardware option that can be used for the evaluation of respiration-induced motion by acquiring and displaying CT images consisting of alt respiratory phases during a breathing cycle

Source page: https://510kreport.com/device/K061187
Methodology: https://510kreport.com/methodology