510(k) K093478

KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM by Trophy — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2010
Date Received
November 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type