FDA 510(k) Application Details - K161163

Device Classification Name	System, Radiation Therapy, Charged-Particle, Medical   More FDA Info for this Device
510(K) Number	K161163
Device Name	System, Radiation Therapy, Charged-Particle, Medical
Applicant	HITACHI, LTD. 2-16-1 HIGACHI-UENO TAITO-KU Tokyo 10-0015 JP Other 510(k) Applications for this Company
Contact	Naoya Nishimura Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	LHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2016
Decision Date	07/13/2016
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