FDA 510(k) Application Details - K982785

Device Classification Name	Digitizer, Image, Radiological   More FDA Info for this Device
510(K) Number	K982785
Device Name	Digitizer, Image, Radiological
Applicant	ARRAY CORP. 3-42-10 YOYOGI, SHIBUYA-KU TOKYO 151-0053 JP Other 510(k) Applications for this Company
Contact	TAKASHI INAMI 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	08/07/1998
Decision Date	10/15/1998
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