# K181804: Alphenix, INFX-8000C/B, V8.0

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Aug 2, 2018 after 27 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: 9 generations back to K890348 (1989). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152697: Infx-8000C, V6.20, Toshibamedical Systems Corporation (2016) Summary page 5.

## Most influential descendants
- K210900: Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 (2021), 1 descendant of its own
- K251645: Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP (2025), 0 descendants of its own

## Recalls of this device
- May 3, 2022 · Class II · Z-1289-2022: CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.
- Dec 20, 2021 · Class II · Z-0492-2022: Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable imag
- Oct 8, 2020 · Class II · Z-0532-2021: There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay w

## 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/K181804
Methodology: https://510kreport.com/methodology