FDA 510(k) Application Details - K991643

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K991643
Device Name	System, Image Processing, Radiological
Applicant	OTECH, INC. 2001 EAST OAKSHORES DR. CROSSROADS, TX 76227 US Other 510(k) Applications for this Company
Contact	HERMAN OOSTERWIJK 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	05/13/1999
Decision Date	06/08/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review