Cleared Special

Akesis Galaxy RTx

K200050 · Akesis, Inc. · Radiology
Feb 2020
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K200050 is an FDA 510(k) clearance for the Akesis Galaxy RTx, a System, Radiation Therapy, Radionuclide (Class II — Special Controls, product code IWB), submitted by Akesis, Inc. (Concord, US). The FDA issued a Cleared decision on February 4, 2020, 25 days after receiving the submission on January 10, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5750.

Submission Details

510(k) Number K200050 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2020
Decision Date February 04, 2020
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IWB — System, Radiation Therapy, Radionuclide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5750

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