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

Canon Medical Systems Corporation · K253584 · 2026-03-10

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) is an AI-enabled medical device from Canon Medical Systems Corporation, listed by FDA (510(k), K253584) with a decision date of 2026-03-10. Review panel: Radiology.

FDA submission numberK253584
Pathway510(k)
CompanyCanon Medical Systems Corporation
Review panel (specialty)Radiology
FDA decision date2026-03-10
DecisionSubstantially Equivalent
Product codeOWB
ClassificationInterventional Fluoroscopic X-Ray System
Device class2
Regulation number892.1650
Review time (calendar days)113
Applicant countryJP

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.