Cleared Traditional

HYPERION X5

K161900 · Cefla S.C. · Radiology

Dec 2016

Decision

151d

Days

Class 2

Risk

About This 510(k) Submission

K161900 is an FDA 510(k) clearance for the HYPERION X5, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Cefla S.C. (Imola, IT). The FDA issued a Cleared decision on December 9, 2016, 151 days after receiving the submission on July 11, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K161900 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2016
Decision Date	December 09, 2016
Days to Decision	151 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.