FDA 510(k) Application Details - K980809

Device Classification Name	Digitizer, Image, Radiological   More FDA Info for this Device
510(K) Number	K980809
Device Name	Digitizer, Image, Radiological
Applicant	LUMISYS, INC. 16303 PANORAMIC WAY SAN LEANDRO, CA 94578 US Other 510(k) Applications for this Company
Contact	GARY J ALLSENBROOK Other 510(k) Applications for this Contact
Regulation Number	892.2030   More FDA Info for this Regulation Number
Classification Product Code	LMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/1998
Decision Date	05/11/1998
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