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FDA 510(k)

Alphenix, INFX-8000V/B, V8.0

K-Number: K181670 · 2018-07-25

ApplicantCanon Medical Systems Corporation
Decision Date2018-07-25
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Alphenix, INFX-8000V/B, V8.0 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 2018-07-25 under 510(k) number K181670. 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, V8.0?

Alphenix, INFX-8000V/B, V8.0 is a medical device that received FDA 510(k) clearance on 2018-07-25. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K181670.

When did Alphenix, INFX-8000V/B, V8.0 receive FDA 510(k) clearance?

Alphenix, INFX-8000V/B, V8.0 received FDA 510(k) clearance on 2018-07-25, under 510(k) number K181670.

Who is the listed applicant for Alphenix, INFX-8000V/B, V8.0?

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, V8.0?

The FDA product code for Alphenix, INFX-8000V/B, V8.0 is OWB.

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Related Devices (Code: 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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