Cleared Special

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

K214084 · Cefla S.C. · Radiology
Jan 2022
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K214084 is an FDA 510(k) clearance for the hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on January 20, 2022, 24 days after receiving the submission on December 27, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K214084 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2021
Decision Date January 20, 2022
Days to Decision 24 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.