FDA 510(k) Application Details - K050092

Device Classification Name	Collimator, Automatic, Radiographic   More FDA Info for this Device
510(K) Number	K050092
Device Name	Collimator, Automatic, Radiographic
Applicant	OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE SANFORD, FL 32771 US Other 510(k) Applications for this Company
Contact	JAMES A PRINCEHOM Other 510(k) Applications for this Contact
Regulation Number	892.1610   More FDA Info for this Regulation Number
Classification Product Code	IZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2005
Decision Date	01/31/2005
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