# K251072: Segmentron Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Dgnct, LLC
- Decided: Sep 9, 2025 after 155 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K190791 (2019). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231757: Ez3D-i /E3, Ewoosoft Co., Ltd. (2023) Summary page 5.

## Indications for use
Segmentron Viewer is a software product intended for processing and manipulating maxillofacial radiographic images. Segmentron Viewer allows users to perform the following functions: 1. Viewing patient images (provides tools for image processing and viewing functions); 2. Reading and 3D visualization of CBCT images; 3. Generating editable 3D STL files (for educational purposes only). The device is indicated for use by medical professionals (such as dentists and radiologists), in patients 14 years and older with permanent teeth. Segmentron Viewer is a web application. It can be used in a network environment.

Source page: https://510kreport.com/device/K251072
Methodology: https://510kreport.com/methodology