Cleared Traditional

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

K261748 is an FDA 510(k) clearance for Dental Cone-beam Computed Tomography (m..., manufactured by Hefei Meyer Optoelectronic Technology, Inc.. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K261748 · Hefei Meyer Optoelectronic Technology, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
56d
Days
Class 2
Risk

K261748 is an FDA 510(k) clearance for the Dental Cone-beam Computed Tomography (mDX-15P Series). Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Hefei Meyer Optoelectronic Technology, Inc. (Hefei, CN). The FDA issued a Cleared decision on July 23, 2026 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hefei Meyer Optoelectronic Technology, Inc. devices

FDA 510(k) Submission Details - K261748

510(k) Number K261748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2026
Decision Date July 23, 2026
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAS Device Classification - Class 2, Special Controls

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Landlink Healthcare Technology (Shanghai) Co., Ltd.
Kyra Kang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OAS X-ray, Tomography, Computed, Dental

All 126
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K261748.
Dental X-ray System
K250839 · Changzhou Boen Zhongding Medical Technology Co., Ltd. · Jun 2026
Dental Cone Beam Computed Tomography System
K260662 · Yofo Medical Technology Co., Ltd. · Jun 2026
medXion NEXUS
K253935 · medXion Technologies, Inc. · May 2026
RCT800
K260462 · Ray Co., Ltd. · Apr 2026
myray ProXIma X6
K252353 · Cefla S.C. · Mar 2026
Primevision 3D
K253959 · Dentsply Sirona · Feb 2026