# K203551: Alphenix, INFX-8000V/B, /S, V9.1

- Pathway: 510(k) (Special)
- Applicant: Canon Medical Systems Corporation
- Decided: Dec 18, 2020 after 14 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K890348 (1989). 33 ancestors in all.
3 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)
- K181670: Alphenix, INFX-8000V/B, V8.0, Canon Medical Systems Corporation (2018) Summary page 5.

## Most influential descendants
- K233107: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 (2024), 2 descendants of its own
- 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.
- Aug 4, 2026 · Class II · Z-3014-2026: Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.

## 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/K203551
Methodology: https://510kreport.com/methodology