FDA 510(k) Application Details - K173631

Device Classification Name	More FDA Info for this Device
510(K) Number	K173631
Device Name	Intelli-C
Applicant	NRT X-ray A/S Birkegaardsvej 16 Hasselager 8361 DK Other 510(k) Applications for this Company
Contact	Jan Malling Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/2017
Decision Date	07/11/2018
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