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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name densitometer, bone
510(k) Number K121716
Device Name TBS INSIGHT
Original Applicant
MEDIMAPS GROUP SA
18 chemin des aulx
plan les ouates,  CH 1228
Original Contact christophe lelong
Regulation Number892.1170
Classification Product Code
KGI  
Date Received06/11/2012
Decision Date 10/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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