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FDA 510(k)

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

K-Number: K253584 · 2026-03-10

ApplicantCanon Medical Systems Corporation
Decision Date2026-03-10
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2026-03-10 under approval number K253584. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) is a medical device that received FDA 510(k) clearance on 2026-03-10. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K253584.

When was Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) approved by the FDA?

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) received FDA 510(k) clearance on 2026-03-10, under approval number K253584.

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

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)?

The FDA product code for Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) is OWB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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