510(k) K033821

KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY by Eastman Kodak Company — Product Code LMC

K033821 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY". The FDA issued a decision of Substantially Equivalent on February 20, 2004. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2004
Date Received
December 9, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type