FDA 510(k) Application Details - K232928

Device Classification Name	More FDA Info for this Device
510(K) Number	K232928
Device Name	DeepContour (V1.0)
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 George Xu 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	09/20/2023
Decision Date	05/07/2024
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