Akesis Galaxy RTx

System, Radiation Therapy, Radionuclide

Akesis Inc

The following data is part of a premarket notification filed by Akesis Inc with the FDA for Akesis Galaxy Rtx.

Pre-market Notification Details

Device IDK200050
510k NumberK200050
Device Name:Akesis Galaxy RTx
ClassificationSystem, Radiation Therapy, Radionuclide
Applicant Akesis Inc 5129 Commercial Circle Concord,  CA  94520
ContactChristopher Brown
CorrespondentChristopher Brown
Akesis Inc 5129 Commercial Circle Concord,  CA  94520
Product CodeIWB  
CFR Regulation Number892.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-10
Decision Date2020-02-04

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