FDA 510(k) Application Details - K241937

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K241937
Device Name	Accelerator, Linear, Medical
Applicant	Klarity Medical & Equipment (GZ) Co., Ltd. No. 14, 3rd Street Shawan GETDD Guangzhou 510730 CN Other 510(k) Applications for this Company
Contact	Guohuang Zhou 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	07/02/2024
Decision Date	03/18/2025
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