FDA 510(k) Application Details - K191503

Device Classification Name	More FDA Info for this Device
510(K) Number	K191503
Device Name	MobileRay Pulse SE Digital Imaging System
Applicant	Portavision Medical LLC 800 Central Avenue Jefferson, LA 70121 US Other 510(k) Applications for this Company
Contact	Terry Ancar 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	06/06/2019
Decision Date	09/04/2019
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