FDA 510(k) Application Details - K021934

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K021934
Device Name	System, Image Processing, Radiological
Applicant	AISOFTW@RE MEDICAL, S.P.A. 719 CATALPA AVE. TEANECK, NJ 07666 US Other 510(k) Applications for this Company
Contact	DIANA UPTON 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	06/12/2002
Decision Date	08/12/2002
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