FDA 510(k) Application Details - K243084

Device Classification Name	More FDA Info for this Device
510(K) Number	K243084
Device Name	BioTraceIO Precision (2.0)
Applicant	TechsoMed Medical Technologies Ltd. Meir Weisgal 2 Rehovot 7654055 IL Other 510(k) Applications for this Company
Contact	Dalia Dickman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	12/27/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review