# K982787: Asteion CT Scanner, TSX-021A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 21, 1998 after 72 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (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.
No later device cites it as a predicate yet.
0 of 2 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.

## Recalls of this device
- 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/K982787
Methodology: https://510kreport.com/methodology