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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,  IT 40026
Applicant Contact Lorenzo Bortolotti
Correspondent
CEFLA S.C.
Via Selice Provinciale 23/A
Imola,  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
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