Dental Cone Beam Computed Tomography System— 510(k) K243337

Name: FDA 510(k) clearance K243337
Creator: U.S. Food and Drug Administration
Published: 2025-04-17

Substantially Equivalent

Yofo Medical Technology Co., Ltd.

FDA 510(k) clearance K243337 for Dental Cone Beam Computed Tomography System, Substantially Equivalent on 2025-04-17. Applicant: Yofo Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Yofo Medical Technology Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2024-10-25
Decision date: 2025-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hefei, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code OAS

view all

K261748 — Dental Cone-beam Computed Tomography (mDX-15P Series)2026-07-23
K250839 — Dental X-ray System2026-06-11
K260662 — Dental Cone Beam Computed Tomography System2026-06-04
K253935 — medXion NEXUS2026-05-15
K260462 — RCT8002026-04-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.