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. · LLZ System, Image Processing, Radiological
Cleared on Sep 6, 2022 as substantially equivalent to K211791 (Ewoosoft Co., Ltd., 2021) after a 54-day review. Its family tree reaches back 3 generations to 2019. 3 later devices descend from it.
- Decided
- Sep 6, 2022
- Review
- 54 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K190791 (2019). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK190791 Ez3D-i/E3Ewoosoft Co., Ltd. · 2019
- 2 generations backK200178 Ez3D-i /E3Ewoosoft Co., Ltd. · 2020
- 1 generation backK211791 Ez3D-i/E3Ewoosoft Co., Ltd. · 2021
- This deviceK222069 Ez3D-i/E3Ewoosoft Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK231757 Ez3D-i /E3Ewoosoft Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK251072 Segmentron ViewerDgnct, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK250005 Clever OneEwoosoft Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K190791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2019 | — |
| −2 | K200178 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2020 | — |
| −1 | K211791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2021 | — |
| 0 (this device) | K222069 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2022 | — |
| +1 | K231757 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2023 | — |
| +2 | K251072 | Segmentron Viewer | Dgnct, LLC | 2025 | — |
| +2 | K250005 | Clever One | Ewoosoft Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K211791 | Ez3D-i/E3Summary page 4…Class: Class II • Product Code: LLZ 5. Predicate Device: • Manufacturer: Ewoosoft Co., Ltd. • Trade/Device name: Ez3D-i /E3 v.5.3 • 510(k) number: K211791 • Regulation number 21 CFR 892.2050 • Regulation name: Picture Archiving and Communications System • Regulatory Cl… | 2021 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231757 | Ez3D-i /E3 | 2023 | 2 |
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 3 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K231757 (Ewoosoft Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K211791.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
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/K222069 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222069: Ez3D-i/E3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222069
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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