Cleared Traditional

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

K190496 · Cefla S.C. · Radiology
Apr 2019
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K190496 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 April 24, 2019, 55 days after receiving the submission on February 28, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K190496 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2019
Decision Date April 24, 2019
Days to Decision 55 days
Submission Type Traditional
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.