FDA 510(k) Application Details - K213155

Device Classification Name	More FDA Info for this Device
510(K) Number	K213155
Device Name	RT-Mind-AI
Applicant	MedMind Technology Co., Ltd. A502-503, Techart Plaza, No.30, Xueyuan Road, Haidian District Beijing 100083 CN Other 510(k) Applications for this Company
Contact	Shaobin Wang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2021
Decision Date	12/15/2021
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