Akesis Galaxy RTx— 510(k) K200050

Substantially Equivalent

Akesis, Inc.

FDA 510(k) clearance K200050 for Akesis Galaxy RTx, Substantially Equivalent on 2020-02-04. Applicant: Akesis, Inc.. Device class: 2.

Clearance details

Applicant: Akesis, Inc.
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2020-01-10
Decision date: 2020-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.