Cleared Traditional

Dental Cone-beam Computed Tomography

K232710 · Yian Medical Technology (Haining) Co., Ltd. · Radiology
Jan 2024
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K232710 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 January 9, 2024, 126 days after receiving the submission on September 5, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K232710 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2023
Decision Date January 09, 2024
Days to Decision 126 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.