FDA 510(k) Application Details - K231378

Device Classification Name	More FDA Info for this Device
510(K) Number	K231378
Device Name	Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
Applicant	Insightec, Ltd. 5 Nachum Heth Street Tirat Carmel 39120 IL Other 510(k) Applications for this Company
Contact	Inbal Ben Tzvi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2023
Decision Date	10/30/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review