FDA 510(k) Application Details - K221706

Device Classification Name	More FDA Info for this Device
510(K) Number	K221706
Device Name	AccuContour
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	Dandan Chen 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	06/13/2022
Decision Date	03/09/2023
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