FDA 510(k) Application Details - K013608

Device Classification Name	More FDA Info for this Device
510(K) Number	K013608
Device Name	DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
Applicant	TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 TUSTIN, CA 92781-2068 US Other 510(k) Applications for this Company
Contact	DIANA THORSON 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	10/31/2001
Decision Date	11/15/2001
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