# K051833: TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jul 15, 2005 after 9 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: 2 generations back to K031469 (2003). 2 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033418: TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners, Toshiba America Medical Systems, In.C (2003) Summary page 1.

## Most influential descendants
- K080211: Model TSX-101A/H/I Aquilion 32/64 SP CT System (2008), 17 descendants of its own
- K101888: Scenaria Whole-Body X-Ray CT System (2011), 15 descendants of its own
- K123509: Scenaria Phase 2 Whole-Body X-Ray CT System (2013), 14 descendants of its own
- K161748: SUPRIA w/guideShot Option (2016), 11 descendants of its own
- K163528: HITACHI Supria Whole-body X-ray CT System Phase 3 (2017), 10 descendants of its own

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

Source page: https://510kreport.com/device/K051833
Methodology: https://510kreport.com/methodology