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FDA 510(k)

Akesis Galaxy RTi

K-Number: K203146 · 2021-03-05

ApplicantAkesis, Inc.
Decision Date2021-03-05
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Akesis Galaxy RTi is a medical device manufactured by Akesis, Inc.. It received FDA 510(k) clearance on 2021-03-05 under approval number K203146. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Akesis Galaxy RTi?

Akesis Galaxy RTi is a medical device that received FDA 510(k) clearance on 2021-03-05. It is manufactured by Akesis, Inc.. The 510(k) number is K203146.

When was Akesis Galaxy RTi approved by the FDA?

Akesis Galaxy RTi received FDA 510(k) clearance on 2021-03-05, under approval number K203146.

What company makes Akesis Galaxy RTi?

Akesis Galaxy RTi is manufactured by Akesis, Inc..

What is the FDA product code for Akesis Galaxy RTi?

The FDA product code for Akesis Galaxy RTi is IWB.

Other Devices by Akesis, Inc.

K190844Akesis Galaxy K200050Akesis Galaxy RTx

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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