Cleared Traditional

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging

K251602 · Canon Medical Systems Corporation · Radiology

Oct 2025

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K251602 is an FDA 510(k) clearance for the Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging, 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 October 10, 2025, 136 days after receiving the submission on May 27, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K251602 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2025
Decision Date	October 10, 2025
Days to Decision	136 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