FDA 510(k) Application Details - K182207

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K182207
Device Name	System, X-Ray, Mobile
Applicant	MinXray, Inc 3611 Commercial Ave Northbrook, IL 60062 US Other 510(k) Applications for this Company
Contact	Keith Kretchmer Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2018
Decision Date	12/14/2018
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