FDA 510(k) Application Details - K223834

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K223834
Device Name	Accelerator, Linear, Medical
Applicant	Manteia Technologies Co., Ltd. 1903, B Tower, Zijin Plaza, No.1811 Huandao East Road Xiamen 361001 CN Other 510(k) Applications for this Company
Contact	Yingkai Lin 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	12/22/2022
Decision Date	07/20/2023
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