FDA 510(k) Application Details - K240094

Device Classification Name	More FDA Info for this Device
510(K) Number	K240094
Device Name	LumiNE US; Lumi
Applicant	Augmedit B.V. Galerij 15 Naarden 1411 LH NL Other 510(k) Applications for this Company
Contact	Claartje Ypma 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	01/12/2024
Decision Date	09/10/2024
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