Cleared Traditional

Dental Cone Beam Computed Tomography System

K243337 · Yofo Medical Technology Co., Ltd. · Radiology
Apr 2025
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K243337 is an FDA 510(k) clearance for the Dental Cone Beam Computed Tomography System, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Yofo Medical Technology Co., Ltd. (Hefei, CN). The FDA issued a Cleared decision on April 17, 2025, 174 days after receiving the submission on October 25, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K243337 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2024
Decision Date April 17, 2025
Days to Decision 174 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.