Dental Cone-beam Computed Tomography (mDX-15P Series)

FDA 510(k) K261748 · Hefei Meyer Optoelectronic Technology, Inc.

Substantially Equivalent

510(k) numberK261748

Submission

Device name
Dental Cone-beam Computed Tomography (mDX-15P Series)
Applicant
Hefei Meyer Optoelectronic Technology, Inc.
Hefei, CN
Received
May 28, 2026
Decision date
July 23, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAS – X-Ray, Tomography, Computed, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

Other 510(k)s with product code OAS

510(k)DeviceApplicantDecision
K250839Dental X-ray SystemOAS · Traditional Changzhou Boen Zhongding Medical Technology Co.…06/11/2026SE
K260662Dental Cone Beam Computed Tomography SystemOAS · Special Yofo Medical Technology Co., Ltd.06/04/2026SE
K253935medXion NEXUSOAS · Traditional medXion Technologies, Inc.05/15/2026SE
K260462RCT800OAS · Special Ray Co., Ltd.04/09/2026SE
K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS · Special VATECH Co., Ltd.03/31/2026SE
K252353myray ProXIma X6OAS · Traditional Cefla S.C.03/10/2026SE
K253959Primevision 3DOAS · Traditional Dentsply Sirona02/05/2026SE
K251798RCT700OAS · Traditional Ray Co., Ltd.11/25/2025SE
K251842Dental Computed Tomography X-ray SystemOAS · Traditional Fussen Technology Co., Ltd.11/13/2025SE
K250060GT300; GT300-COAS · Traditional Genoray Co., Ltd.10/08/2025SE

Questions and answers

When was Dental Cone-beam Computed Tomography (mDX-15P Series) cleared by the FDA?

Dental Cone-beam Computed Tomography (mDX-15P Series) (K261748) received a 510(k) decision of Substantially Equivalent on July 23, 2026, 56 days after the submission was received.

What is the product code of K261748?

The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.