FDA 510(k) Application Details - K180021

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K180021
Device Name	Accelerator, Linear, Medical
Applicant	MEDTEC Inc dba CIVCO Medical Solutions and CIVCO Radiotherap 140 8th Street SE Orange City, IA 51041 US Other 510(k) Applications for this Company
Contact	Alena Newgren 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	01/03/2018
Decision Date	06/29/2018
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