FDA 510(k) Application Details - K070834

Device Classification Name	More FDA Info for this Device
510(K) Number	K070834
Device Name	CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
Applicant	OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE SANFORD, FL 32771 US Other 510(k) Applications for this Company
Contact	JAMES A PRINCEHORN 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	03/27/2007
Decision Date	05/18/2007
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