Cleared Special

Dental CBCT X-ray System

K251642 · Yian Medical Technology (Haining) Co., Ltd. · Radiology
Jun 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K251642 is an FDA 510(k) clearance for the Dental CBCT X-ray System, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Yian Medical Technology (Haining) Co., Ltd. (Haining, Jiaxing, CN). The FDA issued a Cleared decision on June 27, 2025, 29 days after receiving the submission on May 29, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K251642 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2025
Decision Date June 27, 2025
Days to Decision 29 days
Submission Type Special
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.