FDA 510(k) Application Details - K181704

Device Classification Name	More FDA Info for this Device
510(K) Number	K181704
Device Name	Transpara
Applicant	ScreenPoint Medical BV Stationsplein 26 Nijmegen 6512AB NL Other 510(k) Applications for this Company
Contact	Nico Karssemeijer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2018
Decision Date	11/21/2018
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