510(k) K031132

CONSULTIVA CASE INPUT STATION, MODEL CIS-1 by Eastman Kodak Company — Product Code LLZ

K031132 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "CONSULTIVA CASE INPUT STATION, MODEL CIS-1". The FDA issued a decision of Substantially Equivalent on November 26, 2003. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2003
Date Received
April 9, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type