FDA 510(k) Application Details - K030635

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K030635
Device Name	System, Image Processing, Radiological
Applicant	OBSIDIAN MEDICAL TECHNOLOGY, INC. 5108 CORONA CT. PLEASANTON, CA 94588 US Other 510(k) Applications for this Company
Contact	BIANCA GREEN Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2003
Decision Date	03/28/2003
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	Y
Expedited Review