FDA 510(k) Application Details - K231273

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K231273
Device Name	Accelerator, Linear, Medical
Applicant	Wisdom Technologies., Inc. 4th Floor, Building F2, Phase II, Innovation Industrial Park Hefei 230088 CN Other 510(k) Applications for this Company
Contact	Xie Xu 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	05/02/2023
Decision Date	01/05/2024
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