# K152785: XIDF-AWS801, Angio Workstation, V6.20

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Nov 25, 2015 after 61 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K890348 (1989). 51 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150967: XIDF-AWS801, Angio Workstation, V6.10, Toshibamedical Systems Corporation (2015) Summary page 5.

## Most influential descendants
- K172646: XIDF-AWS801, Angio Workstation, V7.0 (2017), 3 descendants of its own
- K181415: XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 (2018), 2 descendants of its own
- K220342: XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 (2022), 1 descendant of its own
- K232526: XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (2023), 0 descendants of its own

## Recalls of this device
- Feb 1, 2017 · Class II · Z-2109-2017: It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio W

## Indications for use
The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging in selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity). When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used in selective catheter angiography procedures for the heart, chest, abdomen, pelvis and brain.

Source page: https://510kreport.com/device/K152785
Methodology: https://510kreport.com/methodology