Hyperion X9 Pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

X-ray, Tomography, Computed, Dental

CEFLA S.C.

The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Hyperion X9 Pro, Newtom Giano Hr, X-radius Trio Plus.

Pre-market Notification Details

Device IDK214084
510k NumberK214084
Device Name:Hyperion X9 Pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
ClassificationX-ray, Tomography, Computed, Dental
Applicant CEFLA S.C. Via Selice Provinciale 23/A Imola,  IT 40026
ContactLorenzo Bortolotti
CorrespondentLorenzo Bortolotti
CEFLA S.C. Via Selice Provinciale 23/A Imola,  IT 40026
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-27
Decision Date2022-01-20

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