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FDA 510(k)

Akesis Galaxy RTx

K-Number: K200050 · 2020-02-04

ApplicantAkesis, Inc.
Decision Date2020-02-04
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Akesis Galaxy RTx is a medical device manufactured by Akesis, Inc.. It received FDA 510(k) clearance on 2020-02-04 under approval number K200050. 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 RTx?

Akesis Galaxy RTx is a medical device that received FDA 510(k) clearance on 2020-02-04. It is manufactured by Akesis, Inc.. The 510(k) number is K200050.

When was Akesis Galaxy RTx approved by the FDA?

Akesis Galaxy RTx received FDA 510(k) clearance on 2020-02-04, under approval number K200050.

What company makes Akesis Galaxy RTx?

Akesis Galaxy RTx is manufactured by Akesis, Inc..

What is the FDA product code for Akesis Galaxy RTx?

The FDA product code for Akesis Galaxy RTx is IWB.

Other Devices by Akesis, Inc.

K190844Akesis Galaxy K203146Akesis Galaxy RTi

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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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