FDA 510(k) Application Details - K171755

Device Classification Name	More FDA Info for this Device
510(K) Number	K171755
Device Name	CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
Applicant	Omega Medical Imaging, LLC 675 Hickman Circle Sanford, FL 32771 US Other 510(k) Applications for this Company
Contact	John Newman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2017
Decision Date	02/09/2018
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