510(k) K083048

NEORAY DR 2520 DIGITAL IMAGING SYSTEM by Portavision Medical, LLC — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2008
Date Received
October 14, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type