# K973908: Auklet CT Scanner, TSX-003A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Dec 22, 1997 after 69 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: 1 generation back to K941745 (1994). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941745: TSX-002A (Xvision) CT Scanner, Toshiba America Medical Systems, In.C (1994) Summary page 1.

## Most influential descendants
- K071546: EOS (2007), 7 descendants of its own
- K120721: EOS (2012), 6 descendants of its own
- K123740: EOS (2013), 5 descendants of its own
- K142773: EOS System (2015), 4 descendants of its own
- K152788: EOS System (2015), 3 descendants of its own

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

Source page: https://510kreport.com/device/K973908
Methodology: https://510kreport.com/methodology