# K233107: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Aug 30, 2024 after 338 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K890348 (1989). 34 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203551: Alphenix, INFX-8000V/B, /S, V9.1, Canon Medical Systems Corporation (2020) Summary page 6.

## Most influential descendants
- K251602: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (2025), 1 descendant of its own
- K253584: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (2026), 0 descendants of its own

## Recalls of this device
- Oct 12, 2026 · Not classified · Z-0291-2027: Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
- Dec 19, 2025 · Class II · Z-1179-2026: It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. 
- Sep 2, 2025 · Class II · Z-0037-2026: It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, cov

## Indications for use
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

Source page: https://510kreport.com/device/K233107
Methodology: https://510kreport.com/methodology