# K132106: Infinix Angio Workstation W/DTS Software

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 12, 2013 after 127 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K890348 (1989). 30 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123097: Dose Tracking System Model Xidf-DTS801, Toshiba America Medical Systems, In.C (2013) Summary page 1.
- K120073: Infx-8000V with, Toshibamedical Systems Corporation (2012) Summary page 1.

## Most influential descendants
- K141541: Xidf-AWS801, Angio Workstation, V5.31 (2014), 7 descendants of its own
- K142736: XIDF-AWS801, Angio Workstation, v5.31 (2015), 6 descendants of its own
- K150967: XIDF-AWS801, Angio Workstation, V6.10 (2015), 5 descendants of its own
- K152785: XIDF-AWS801, Angio Workstation, V6.20 (2015), 4 descendants of its own
- K172646: XIDF-AWS801, Angio Workstation, V7.0 (2017), 3 descendants of its own

## Indications for use
The Angio Workstation is used in combination with an interventional angiography system (Infinix-i series systems and INFX-8000V and INFX-8000C systems) to provide 2D and 3D imaging and Dose Tracking System functions in selective catheter angiography for the heart, chest, and abdomen.

Source page: https://510kreport.com/device/K132106
Methodology: https://510kreport.com/methodology