Cleared Traditional

Dental Computed Tomography X-ray System

K251842 · Fussen Technology Co., Ltd. · Radiology
Nov 2025
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K251842 is an FDA 510(k) clearance for the Dental Computed Tomography X-ray System, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Fussen Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 13, 2025, 150 days after receiving the submission on June 16, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K251842 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2025
Decision Date November 13, 2025
Days to Decision 150 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.