FDA 510(k) Application Details - K223639

Device Classification Name	More FDA Info for this Device
510(K) Number	K223639
Device Name	VisAble.IO
Applicant	TechsoMed Meir Weisgal 2 Rehovot 7654055 IL Other 510(k) Applications for this Company
Contact	Dalia Dickman, PhD Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2022
Decision Date	08/28/2023
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