FDA 510(k) Application Details - K191310

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K191310
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	Imaging Engineering, LLC 1318 NW 7th Ave Cape Coral, FL 33993 US Other 510(k) Applications for this Company
Contact	George Jachode 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	05/15/2019
Decision Date	06/10/2019
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