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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K121838
Device Name LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
Original Applicant
LIEBEL-FLARSHEIM
2111 east galbraith rd
cincinnati,  OH  45237
Original Contact craig buehler
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/22/2012
Decision Date 07/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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