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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K161900
Device Name HYPERION X5
Applicant
Cefla S.C.
Via Selice Provinciale 13/A
Imola,  IT 40026
Applicant Contact SILVIA SANSAVINI
Correspondent
Isemed S.R.L.
Via A. Bonetti 3/A
Imola,  IT 40026
Correspondent Contact MAURIZIO PANTALEONI
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
MUH  
Date Received07/11/2016
Decision Date 12/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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