FDA 510(k) Application Details - K243769

Device Classification Name	More FDA Info for this Device
510(K) Number	K243769
Device Name	QFR (3.0)
Applicant	QFR Solutions bv Schuttersveld 9 Leiden 2316XG NL Other 510(k) Applications for this Company
Contact	Bob Goedhart Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2024
Decision Date	04/04/2025
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