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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, radiation therapy, radionuclide
510(k) Number K200050
Device Name Akesis Galaxy RTx
Applicant
Akesis Inc
5129 Commercial Circle
Concord,  CA  94520
Applicant Contact Christopher Brown
Correspondent
Akesis Inc
5129 Commercial Circle
Concord,  CA  94520
Correspondent Contact Christopher Brown
Regulation Number892.5750
Classification Product Code
IWB  
Date Received01/10/2020
Decision Date 02/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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