510(k) · Cleared
ClearedEz3D-i /E3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ewoosoft Co., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Jul 14, 2023 as substantially equivalent to K222069 (Ewoosoft Co., Ltd., 2022) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 2019. 2 later devices descend from it.
- Decided
- Jul 14, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K190791 (2019). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK190791 Ez3D-i/E3Ewoosoft Co., Ltd. · 2019
- 3 generations backK200178 Ez3D-i /E3Ewoosoft Co., Ltd. · 2020
- 2 generations backK211791 Ez3D-i/E3Ewoosoft Co., Ltd. · 2021
- 1 generation backK222069 Ez3D-i/E3Ewoosoft Co., Ltd. · 2022
- This deviceK231757 Ez3D-i /E3Ewoosoft Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK251072 Segmentron ViewerDgnct, LLC · 2025
- Descendant · cites it directly · 0 of its ownK250005 Clever OneEwoosoft Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K190791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2019 | — |
| −3 | K200178 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2020 | — |
| −2 | K211791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2021 | — |
| −1 | K222069 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2022 | — |
| 0 (this device) | K231757 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2023 | — |
| +1 | K251072 | Segmentron Viewer | Dgnct, LLC | 2025 | — |
| +1 | K250005 | Clever One | Ewoosoft Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
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 23.5 · 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? (2)
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 |
|---|---|---|---|
| * | K222069 | Ez3D-i/E3Summary page 5…• Product Code: LLZ 5. Predicate Device: • Manufacturer: Ewoosoft Co., Ltd. • Trade/Device name: Ez3D-i /E3 • Version #: v5.4 • 510(k) number: K222069 • Regulation number 21 CFR 892.2050 • Regulation name: Picture Archiving and Communications System • Regulatory Cl… | 2022 |
| * | K211791 | Ez3D-i/E3Summary page 7…l Equivalence Discussion Ez3D-i v5.5 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device (K211791, Ez3D-i /E3). Page 3 of 4 The subject device and the pre… | 2021 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K251072 (Dgnct, LLC, 2025) has gone furthest, with 0 descendants of its own.
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. 2023, 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?
Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231757: Ez3D-i /E3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231757
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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