FDA 510(k) Application Details - K243005

Device Classification Name	More FDA Info for this Device
510(K) Number	K243005
Device Name	AudaxCeph Cephalogram Analysis Software
Applicant	Audax d.o.o. TehnoloÜki park 18c, 1000 Ljubljana SI Other 510(k) Applications for this Company
Contact	Peter Kobal 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	09/26/2024
Decision Date	05/30/2025
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