510(k) · Cleared
ClearedSegmentron Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dgnct, LLC · QIH Automated Radiological Image Processing Software
Cleared on Sep 9, 2025 as substantially equivalent to K231757 (Ewoosoft Co., Ltd., 2023) after a 155-day review. Its family tree reaches back 5 generations to 2019.
- Decided
- Sep 9, 2025
- Review
- 155 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K190791 (2019). No later device cites it as a predicate yet.
- Root · 5 generations backK190791 Ez3D-i/E3Ewoosoft Co., Ltd. · 2019
- 4 generations backK200178 Ez3D-i /E3Ewoosoft Co., Ltd. · 2020
- 3 generations backK211791 Ez3D-i/E3Ewoosoft Co., Ltd. · 2021
- 2 generations backK222069 Ez3D-i/E3Ewoosoft Co., Ltd. · 2022
- 1 generation backK231757 Ez3D-i /E3Ewoosoft Co., Ltd. · 2023
- This deviceK251072 Segmentron ViewerDgnct, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K190791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2019 | — |
| −4 | K200178 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2020 | — |
| −3 | K211791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2021 | — |
| −2 | K222069 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2022 | — |
| −1 | K231757 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2023 | — |
| 0 (this device) | K251072 | Segmentron Viewer | Dgnct, LLC | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231757 | Ez3D-i /E3Summary page 5…Viewer Device Classification: CFR 892.2050 Medical image management and processing system Regulatory Class: II Product Code: QIH Predicate Device: Ez3D-i/E3 device (K231757) (Ewoosoft Co., Ltd.) Device Description Segmentron Viewer is a semi-automated software as a medical device (SaMD) for dental im… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K231757.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251072 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251072: Segmentron Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251072
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026