Cleared Traditional

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)

K253584 · Canon Medical Systems Corporation · Radiology
Mar 2026
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K253584 is an FDA 510(k) clearance for the Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension), a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on March 10, 2026, 113 days after receiving the submission on November 17, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K253584 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2025
Decision Date March 10, 2026
Days to Decision 113 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OWB — Interventional Fluoroscopic X-ray System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy