Cleared Special

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

K232526 · Canon Medical Systems Corporation · Radiology
Sep 2023
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K232526 is an FDA 510(k) clearance for the XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on September 12, 2023, 22 days after receiving the submission on August 21, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K232526 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2023
Decision Date September 12, 2023
Days to Decision 22 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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