510(k) K060137

KODAK ECLIPSE IMAGE PROCESSING SOFTWARE by Eastman Kodak Company — Product Code MQB

K060137 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK ECLIPSE IMAGE PROCESSING SOFTWARE". The FDA issued a decision of Substantially Equivalent on March 16, 2006. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2006
Date Received
January 19, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type