510(k) K001750

MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM by Barco NV Display Systems — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2000
Date Received
June 8, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type