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FDA 510(k)

Alphenix, INFX-8000V/B, /S, V9.1

K-Number: K203551 · 2020-12-18

ApplicantCanon Medical Systems Corporation
Decision Date2020-12-18
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Alphenix, INFX-8000V/B, /S, V9.1 is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2020-12-18 under 510(k) number K203551. 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, /S, V9.1?

Alphenix, INFX-8000V/B, /S, V9.1 is a medical device that received FDA 510(k) clearance on 2020-12-18. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K203551.

When did Alphenix, INFX-8000V/B, /S, V9.1 receive FDA 510(k) clearance?

Alphenix, INFX-8000V/B, /S, V9.1 received FDA 510(k) clearance on 2020-12-18, under 510(k) number K203551.

Who is the listed applicant for Alphenix, INFX-8000V/B, /S, V9.1?

The FDA 510(k) record lists Canon Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alphenix, INFX-8000V/B, /S, V9.1?

The FDA product code for Alphenix, INFX-8000V/B, /S, V9.1 is OWB.

Other records listing Canon Medical Systems Corporation as applicant

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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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