FDA 510(k) Application Details - K143560

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K143560
Device Name	Accelerator, Linear, Medical
Applicant	Accuthera Inc. 2-8-22 Kurigi, Asaoku Kawasaki 215-0033 JP Other 510(k) Applications for this Company
Contact	Eiji Tanabe 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	12/16/2014
Decision Date	10/05/2015
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