FDA 510(k) Application Details - K173395

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K173395
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	General Medical Merate S.P.A Via Partigiani, 25 Seriate 24068 IT Other 510(k) Applications for this Company
Contact	Luca Bianchessi 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	10/30/2017
Decision Date	05/21/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review