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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
Applicant
LIEBEL-FLARSHEIM
2111 EAST GALBRAITH RD
CINCINNATI,  OH  45237
Applicant Contact CRAIG BUEHLER
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/22/2012
Decision Date 07/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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