FDA 510(k) Application Details - K203172

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K203172
Device Name	Accelerator, Linear, Medical
Applicant	Elekta Solutions AB Kungstensgatan 18, Box 7593 Stockholm SE-10393 SE Other 510(k) Applications for this Company
Contact	Melinda Smith Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2020
Decision Date	12/18/2020
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