FDA 510(k) Application Details - K011582

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K011582
Device Name	System, Image Processing, Radiological
Applicant	MEDIS MEDICAL IMAGING SYSTEMS, B.V. POORTGEBOUW RIJNSBURGERWEG 10 LEIDEN 2333 AA NL Other 510(k) Applications for this Company
Contact	J.J. HOLLANDER 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	05/23/2001
Decision Date	07/31/2001
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