Akesis Galaxy RTi— 510(k) K203146

Substantially Equivalent

Akesis, Inc.

FDA 510(k) clearance K203146 for Akesis Galaxy RTi, Substantially Equivalent on 2021-03-05. Applicant: Akesis, Inc..

Clearance details

Applicant: Akesis, Inc.
Product code: Code IWB
Advisory panel: Radiology
Date received: 2020-10-21
Decision date: 2021-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

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