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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accelerator, linear, medical
510(k) Number K121845
Device Name SDX SYSTEM
Applicant
DYN'R SAS
74 Cours Gambetta
Aix en Provence,  FR 13100
Applicant Contact TIM LAWTON
Correspondent
DYN'R SAS
74 Cours Gambetta
Aix en Provence,  FR 13100
Correspondent Contact TIM LAWTON
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
LHN  
Date Received06/25/2012
Decision Date 10/19/2012
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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