Cleared Traditional

HYPERION X9

K123381 · Cefla S.C. · Radiology
May 2013
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K123381 is an FDA 510(k) clearance for the HYPERION X9, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Cefla S.C. (Ormond Beach, US). The FDA issued a Cleared decision on May 10, 2013, 190 days after receiving the submission on November 1, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K123381 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2012
Decision Date May 10, 2013
Days to Decision 190 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

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.