510(k) K073435

KODAK 9000, KODAK 9000 3D by Trophy — Product Code MUH

K073435 is an FDA 510(k) premarket notification submitted by Trophy for the device "KODAK 9000, KODAK 9000 3D". The FDA issued a decision of Substantially Equivalent on February 11, 2008. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Trophy has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2008
Date Received
December 6, 2007
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