# K210900: Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2

- Pathway: 510(k) (Special)
- Applicant: Canon Medical Systems Corporation
- Decided: Apr 12, 2021 after 17 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K890348 (1989). 22 ancestors in all.
1 later device descends 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)
- K181804: Alphenix, INFX-8000C/B, V8.0, Canon Medical Systems Corporation (2018) Summary page 5.

## Most influential descendants
- 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
- Oct 12, 2026 · Not classified · Z-0289-2027: 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 26, 2026 · Class II · Z-0108-2027: Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
- 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.
- Dec 19, 2025 · Class II · Z-1176-2026: 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
- Nov 15, 2023 · Class II · Z-1154-2024: VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stri
- Jun 22, 2023 · Class II · Z-2392-2023: The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but proced

## 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/K210900
Methodology: https://510kreport.com/methodology