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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K253584
Device Name Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-Shi,  JP 324-8550
Applicant Contact Orlando Tadeo, Jr.
Correspondent
Canon Medical Systems, USA
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact Jonathan Toy
Regulation Number892.1650
Classification Product Code
OWB  
Date Received11/17/2025
Decision Date 03/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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