FDA 510(k) Application Details - K232096

Device Classification Name	More FDA Info for this Device
510(K) Number	K232096
Device Name	Transpara Density 1.0.0
Applicant	Screenpoint Medical B.V. Mercator II, 7th floor, Toernooiveld 300 Nijmegen 6525EC NL Other 510(k) Applications for this Company
Contact	Robin Barwegen 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	07/13/2023
Decision Date	12/11/2023
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