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

- Pathway: 510(k) (Traditional)
- Applicant: Hefei Meyer Optoelectronic Technology, Inc.
- Decided: Jul 23, 2026 after 56 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K801623 (1980). 140 ancestors in all.
No later device cites it as a predicate yet.
0 of 141 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230985: Planmeca Viso, Planmeca Oy (2023) Summary page 5.

## Indications for use
The equipment is intended to produce two-dimensional (2D) or three-dimensional (3D) images of the human dental, maxillofacial regions and/or skull as diagnostic support for adult and pediatric patients.

Source page: https://510kreport.com/device/K261748
Methodology: https://510kreport.com/methodology