FDA 510(k) Application Details - K121293

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K121293
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	OMEGA MEDICAL IMAGING, LLC 675 HICKMAN CIRCLE SANFORD, FL 32771 US Other 510(k) Applications for this Company
Contact	BRIAN J FLEMING 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	04/30/2012
Decision Date	07/26/2012
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