Dental Cone-beam Computed Tomography (mDX-15P Series)— 510(k) K261748

Name: FDA 510(k) clearance K261748
Creator: U.S. Food and Drug Administration
Published: 2026-07-23

Substantially Equivalent

Hefei Meyer Optoelectronic Technology, Inc.

FDA 510(k) clearance K261748 for Dental Cone-beam Computed Tomography (mDX-15P Series), Substantially Equivalent on 2026-07-23. Applicant: Hefei Meyer Optoelectronic Technology, Inc.. Device class: 2.

Clearance details

Applicant: Hefei Meyer Optoelectronic Technology, Inc.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2026-05-28
Decision date: 2026-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hefei, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code OAS

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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
K260093 — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)2026-03-31

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