FDA 510(k) Application Details - K974619

Device Classification Name	Digitizer, Image, Radiological   More FDA Info for this Device
510(K) Number	K974619
Device Name	Digitizer, Image, Radiological
Applicant	AFP IMAGING CORP. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	MARY MCNAMARA-CULLINANE 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	12/11/1997
Decision Date	02/25/1998
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