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FDA 510(k)

Ultimax-i, DREX-UI80 (V1.60)

K-Number: K181834 · 2018-07-19

ApplicantCanon Medical Systems Corporation
Decision Date2018-07-19
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ultimax-i, DREX-UI80 (V1.60) is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2018-07-19 under approval number K181834. 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 Ultimax-i, DREX-UI80 (V1.60)?

Ultimax-i, DREX-UI80 (V1.60) is a medical device that received FDA 510(k) clearance on 2018-07-19. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K181834.

When was Ultimax-i, DREX-UI80 (V1.60) approved by the FDA?

Ultimax-i, DREX-UI80 (V1.60) received FDA 510(k) clearance on 2018-07-19, under approval number K181834.

What company makes Ultimax-i, DREX-UI80 (V1.60)?

Ultimax-i, DREX-UI80 (V1.60) is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Ultimax-i, DREX-UI80 (V1.60)?

The FDA product code for Ultimax-i, DREX-UI80 (V1.60) 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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