510(k) K033088

SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 by Sectra AB — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2003
Date Received
September 29, 2003
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