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FDA 510(k)

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

K-Number: K182415 · 2018-09-28

ApplicantCanon Medical Systems Corporation
Decision Date2018-09-28
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Alphenix, INFX-8000F/B, V8.0 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2018-09-28 under approval number K182415. 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-8000F/B, V8.0?

Alphenix, INFX-8000F/B, V8.0 is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K182415.

When was Alphenix, INFX-8000F/B, V8.0 approved by the FDA?

Alphenix, INFX-8000F/B, V8.0 received FDA 510(k) clearance on 2018-09-28, under approval number K182415.

What company makes Alphenix, INFX-8000F/B, V8.0?

Alphenix, INFX-8000F/B, V8.0 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Alphenix, INFX-8000F/B, V8.0?

The FDA product code for Alphenix, INFX-8000F/B, V8.0 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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