FDA 510(k) Application Details - K191801

Device Classification Name	System, Radiation Therapy, Charged-Particle, Medical   More FDA Info for this Device
510(K) Number	K191801
Device Name	System, Radiation Therapy, Charged-Particle, Medical
Applicant	Hitachi Ltd. 3-1-1, Saiwai-cho Hitachi-shi 317-8511 JP Other 510(k) Applications for this Company
Contact	Tomoyuki Seino 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	07/03/2019
Decision Date	09/13/2019
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