FDA 510(k) Application Details - K191504

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K191504
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	Radiology Information Systems, Inc. 43676 Trade Center Place, Ste 100 Dulles, VA 20166 US Other 510(k) Applications for this Company
Contact	Chen-Tai Ma Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2019
Decision Date	08/16/2019
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