510(k) K010571

ADC QS/IPD WORKSTATION by Agfa Corp. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2001
Date Received
February 26, 2001
Clearance Type
Special
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