FDA 510(k) Application Details - K243880

Device Classification Name	More FDA Info for this Device
510(K) Number	K243880
Device Name	Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
Applicant	Wuxi Hisky Medical Technologies Co., Ltd. Room B401, 530 Plaza, University Science Park Taihu International Science & Technology Park Wuxi 214135 CN Other 510(k) Applications for this Company
Contact	Jinhua Shao Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2024
Decision Date	06/17/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review