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FDA 510(k)

Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2

K-Number: K210900 · 2021-04-12

ApplicantCanon Medical Systems Corporation
Decision Date2021-04-12
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 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 2021-04-12 under 510(k) number K210900. 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-8000C/B, INFX-8000C/S, V9.2?

Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 is a medical device that received FDA 510(k) clearance on 2021-04-12. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K210900.

When did Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 receive FDA 510(k) clearance?

Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 received FDA 510(k) clearance on 2021-04-12, under 510(k) number K210900.

Who is the listed applicant for Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2?

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-8000C/B, INFX-8000C/S, V9.2?

The FDA product code for Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 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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