FDA 510(k) Application Details - K970947

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K970947
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE SANFORD, FL 32771 US Other 510(k) Applications for this Company
Contact	DOUGLAS COON 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	03/14/1997
Decision Date	05/14/1997
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