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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 K214084
Device Name hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
Applicant
Cefla S.C.
Via Selice Provinciale 23/A
Imola (Bo),  IT 40026
Applicant Contact Lorenzo Bortolotti
Correspondent
Cefla S.C.
Via Selice Provinciale 23/A
Imola (Bo),  IT 40026
Correspondent Contact Lorenzo Bortolotti
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
MUH  
Date Received12/27/2021
Decision Date 01/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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