Cleared Traditional

hyperion X5, NewTom GO, X-RADiUS COMPACT

K200688 · Cefla S.C. · Radiology

Apr 2020

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K200688 is an FDA 510(k) clearance for the hyperion X5, NewTom GO, X-RADiUS COMPACT, 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 April 9, 2020, 24 days after receiving the submission on March 16, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K200688 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 2020
Decision Date	April 09, 2020
Days to Decision	24 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.