FDA 510(k) Application Details - K232854

Device Classification Name	System, Radiation Therapy, Radionuclide   More FDA Info for this Device
510(K) Number	K232854
Device Name	System, Radiation Therapy, Radionuclide
Applicant	Elekta Solutions AB Kungstensgatan 18 Box 7593 Stockholm SE-10393 SE Other 510(k) Applications for this Company
Contact	Simon Sjohage 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	09/15/2023
Decision Date	02/08/2024
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