FDA 510(k) Application Details - K223646

Device Classification Name	More FDA Info for this Device
510(K) Number	K223646
Device Name	IB Lab LAMA
Applicant	IB Lab GmbH Zehetnergasse 6/2/2 Vienna 1140 AT Other 510(k) Applications for this Company
Contact	Richard Ljuhar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2022
Decision Date	06/16/2023
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