510(k) K063781

PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE by Philips Medical Systems North America Co. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2007
Date Received
December 21, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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