Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K261748 · 2026-07-23

ApplicantHefei Meyer Optoelectronic Technology, Inc.
Decision Date2026-07-23
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dental Cone-beam Computed Tomography (mDX-15P Series) is the device name listed in this FDA 510(k) record. The listed applicant is Hefei Meyer Optoelectronic Technology, Inc.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K261748. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Cone-beam Computed Tomography (mDX-15P Series)?

Dental Cone-beam Computed Tomography (mDX-15P Series) is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Hefei Meyer Optoelectronic Technology, Inc.. The 510(k) number is K261748.

When did Dental Cone-beam Computed Tomography (mDX-15P Series) receive FDA 510(k) clearance?

Dental Cone-beam Computed Tomography (mDX-15P Series) received FDA 510(k) clearance on 2026-07-23, under 510(k) number K261748.

Who is the listed applicant for Dental Cone-beam Computed Tomography (mDX-15P Series)?

The FDA 510(k) record lists Hefei Meyer Optoelectronic Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Cone-beam Computed Tomography (mDX-15P Series)?

The FDA product code for Dental Cone-beam Computed Tomography (mDX-15P Series) is OAS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04686084Dual Energy Cone-Beam Computed Tomography (DE-CBCT) Assessment of Jaw Bone DensityCOMPLETEDNCT06308640Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed TomographyACTIVE_NOT_RECRUITINGNCT06481761The Effectiveness of Double-slot Brackets Versus Single-slot Brackets on the Rate of Canine RetractionCOMPLETEDNCT07240493BMP Effect on Implant Stability and Marginal Bone Level After Immediate PlacementCOMPLETEDNCT07513792The Impact of a 3D Imaging Tool on Reducing Gum Recession During Orthodontic Treatment With AlignersRECRUITINGNCT07518615Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System FalconRECRUITING

Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.K252353myray ProXIma X6Cefla S.C.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑