FDA 510(k) Application Details - K203146

Device Classification Name	System, Radiation Therapy, Radionuclide   More FDA Info for this Device
510(K) Number	K203146
Device Name	System, Radiation Therapy, Radionuclide
Applicant	Akesis Inc 5129 Commercial Circle Concord, CA 94520 US Other 510(k) Applications for this Company
Contact	Christopher Brown Other 510(k) Applications for this Contact
Regulation Number	892.5750   More FDA Info for this Regulation Number
Classification Product Code	IWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/2020
Decision Date	03/05/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review