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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 the device name listed in this FDA 510(k) record. The listed applicant is Akesis, Inc.. It received FDA 510(k) clearance on 2020-02-04 under 510(k) 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. The listed applicant is Akesis, Inc.. The 510(k) number is K200050.

When did Akesis Galaxy RTx receive FDA 510(k) clearance?

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

Who is the listed applicant for Akesis Galaxy RTx?

The FDA 510(k) record lists Akesis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Akesis Galaxy RTx?

The FDA product code for Akesis Galaxy RTx is IWB.

Other records listing Akesis, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203146Akesis Galaxy RTiK190844Akesis Galaxy

Related Devices (Code: IWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions ABK232854Leksell GammaPlan (LGP)Elekta Solutions ABK222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions ABK203250TaiChiCOur United CorporationK203146Akesis Galaxy RTiAkesis, Inc.K190844Akesis GalaxyAkesis, Inc.

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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