# K232526: XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

- Pathway: 510(k) (Special)
- Applicant: Canon Medical Systems Corporation
- Decided: Sep 12, 2023 after 22 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: 18 generations back to K890348 (1989). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220342: XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3, Canon Medical Systems Corporation (2022) Summary page 5.

## Indications for use
The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Alphenix series systems, Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging of 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 with selective catheter angiography procedures for the heart, chest abdomen, pelvis and brain.

Source page: https://510kreport.com/device/K232526
Methodology: https://510kreport.com/methodology