FDA 510(k) Application Details - K221922

Device Classification Name	More FDA Info for this Device
510(K) Number	K221922
Device Name	Trinias
Applicant	Shimadzu Corporation Medical Systems Division 1, Nishinokyo-Kuwabaracho, Nakagyo-ku Kyoto 604-8511 JP Other 510(k) Applications for this Company
Contact	Koichi Kataoka Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2022
Decision Date	07/28/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review