510(k) K060079

KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM by Eastman Kodak Company — Product Code MUH

K060079 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 8, 2006. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2006
Date Received
January 10, 2006
Clearance Type
Special
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