# K123097: Dose Tracking System Model Xidf-DTS801

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Feb 13, 2013 after 134 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: 2 generations back to K853753 (1985). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982319: Caregraph, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.

## Most influential descendants
- K132106: Infinix Angio Workstation W/DTS Software (2013), 8 descendants of its own
- 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

## Indications for use
DTS is intended to display an approximation of both skin dose distribution and skin dose rate in real time during fluoroscopic interventional procedures of cardiac angiography. This software is intended for use on the Toshiba INFX-8000F CSi cardiac labs.

Source page: https://510kreport.com/device/K123097
Methodology: https://510kreport.com/methodology