Cleared Special

Dental Cone-beam Computed Tomography

K240855 · Yian Medical Technology (Haining) Co., Ltd. · Radiology
Apr 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K240855 is an FDA 510(k) clearance for the Dental Cone-beam Computed Tomography, 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 April 25, 2024, 28 days after receiving the submission on March 28, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K240855 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2024
Decision Date April 25, 2024
Days to Decision 28 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.