MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K021829
Device Name MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
Original Applicant
EASTMAN KODAK COMPANY
343 state st.
rochester, 
NY 
14650 -1131

Original Contact carol ryerson
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 06/04/2002
Decision Date 07/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No