FDA 510(k) Application Details - K021913

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K021913
Device Name	System, Image Processing, Radiological
Applicant	3D MED CO., LTD. 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	892.2050   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	06/11/2002
Decision Date	09/06/2002
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