510(k) K072766

PVMED DDR 2520 DIGITAL IMAGING SYSTEM by Portavision Medical — Product Code IXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2007
Date Received
September 28, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, X-Ray, Electrostatic
Device Class
Class II
Regulation Number
892.1630
Review Panel
RA
Submission Type