FDA 510(k) Application Details - K193535

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K193535
Device Name	System, X-Ray, Mobile
Applicant	Livermoretech Inc. 801 North Jupiter Rd, Suite 200 Plano, TX 75074 US Other 510(k) Applications for this Company
Contact	Jae Hong Kim 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	12/20/2019
Decision Date	05/07/2020
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