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FDA 510(k)

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

K-Number: K251602 · 2025-10-10

ApplicantCanon Medical Systems Corporation
Decision Date2025-10-10
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2025-10-10 under approval number K251602. 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?

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging is a medical device that received FDA 510(k) clearance on 2025-10-10. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K251602.

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

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging received FDA 510(k) clearance on 2025-10-10, under approval number K251602.

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

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

The FDA product code for Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging 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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