FDA 510(k) Application Details - K233925

Device Classification Name	More FDA Info for this Device
510(K) Number	K233925
Device Name	Relu Creator
Applicant	Relu BV Kapeldreef 60 Leuven 3001 BE Other 510(k) Applications for this Company
Contact	Holger Willems 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	12/13/2023
Decision Date	06/13/2024
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