FDA 510(k) Application Details - K223347

Device Classification Name	More FDA Info for this Device
510(K) Number	K223347
Device Name	UltraSight AI Guidance
Applicant	UltraSight Inc. 1 Hamada St. Rehovot 7670301 IL Other 510(k) Applications for this Company
Contact	Davidi Vortman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2022
Decision Date	07/24/2023
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