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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
Original Applicant
74 cours gambetta
aix en provence,  FR 13100
Original Contact tim lawton
Regulation Number892.5050
Classification Product Code
Subsequent Product Code
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