FDA 510(k) Application Details - K001012

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K001012
Device Name	System, Image Processing, Radiological
Applicant	WELLINGTON MEDICAL SYSTEMS, INC. 19 HARVEST AVE. DARTMOUTH, MA 02747 US Other 510(k) Applications for this Company
Contact	SCOTT AUGUST 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	03/29/2000
Decision Date	06/13/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review