FDA 510(k) Application Details - K222745

Device Classification Name	More FDA Info for this Device
510(K) Number	K222745
Device Name	Axial3D Insight
Applicant	Axial Medical Printing Limited 17A Ormeau Avenue Belfast BT2 8HD GB Other 510(k) Applications for this Company
Contact	Jenna McGarry 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	09/12/2022
Decision Date	07/03/2023
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