# K150967: XIDF-AWS801, Angio Workstation, V6.10

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jun 18, 2015 after 66 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: 13 generations back to K890348 (1989). 50 ancestors in all.
5 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)
- K142736: XIDF-AWS801, Angio Workstation, v5.31, Toshibamedical Systems Corporation (2015) Summary page 5.

## Most influential descendants
- 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
- 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 24, 2016 · Class II · Z-2188-2016: During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condit

## 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/K150967
Methodology: https://510kreport.com/methodology