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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K060440
Device Name CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER
Applicant
Codonics, Inc.
17991 Englewood Dr.
Middleburg Heights,  OH  44130
Applicant Contact ALAN DESANTIS
Correspondent
Codonics, Inc.
17991 Englewood Dr.
Middleburg Heights,  OH  44130
Correspondent Contact ALAN DESANTIS
Regulation Number892.2040
Classification Product Code
LMC  
Date Received02/21/2006
Decision Date 03/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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