# K130960: Suresubtraction Ortho

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Aug 20, 2013 after 137 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 K031469 (2003). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051833: TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner, Toshiba America Medical Systems, In.C (2005) Summary page 2.
- K122109: Aquilion One Vision, V4.90, Toshiba America Medical Systems, In.C (2012) Summary page 2.

## Most influential descendants
- K151212: Ziostation2 (2015), 2 descendants of its own
- K181892: Ziostation2 (2018), 1 descendant of its own
- K200315: Ziostation2 (2020), 0 descendants of its own

## Indications for use
SURSubtradtion Ortho software is intended to generate subtraction images and improve the visualization of contrast enhancement. The system can load two or more CT images with and without contrast enhancement. When used by a qualified physician, a potential application is to determine the course of treatment.

Source page: https://510kreport.com/device/K130960
Methodology: https://510kreport.com/methodology