FDA 510(k) Application Details - K190373

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K190373
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	SHIMADZU corporation 1 Nishinokyo-Kuwabaracho Nakagyo-ku Kyoto 604-8511 JP Other 510(k) Applications for this Company
Contact	Toshio Kadowaki 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	02/19/2019
Decision Date	03/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review