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 Feb 25, 2020 as substantially equivalent to K190791 (Ewoosoft Co., Ltd., 2019) after a 32-day review. Its family tree reaches back 1 generation to 2019. 8 later devices descend from it.
- Decided
- Feb 25, 2020
- Review
- 32 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K190791 (2019). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK190791 Ez3D-i/E3Ewoosoft Co., Ltd. · 2019
- This deviceK200178 Ez3D-i /E3Ewoosoft Co., Ltd. · 2020
- Descendant · cites it directly · 4 of its ownK211791 Ez3D-i/E3Ewoosoft Co., Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK222069 Ez3D-i/E3Ewoosoft Co., Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK231757 Ez3D-i /E3Ewoosoft Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK211700 EzDent WebEwoosoft Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK230468 EzDent WebEwoosoft Co., Ltd. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K211791Ez3D-i/E3Ewoosoft Co., Ltd. · 2021 · cites it directly4descendants
- K222069Ez3D-i/E3Ewoosoft Co., Ltd. · 2022 · 2 generations on3descendants
- K231757Ez3D-i /E3Ewoosoft Co., Ltd. · 2023 · 2 generations on2descendants
- K211700EzDent WebEwoosoft Co., Ltd. · 2021 · cites it directly2descendants
- K230468EzDent WebEwoosoft Co., Ltd. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K190791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2019 | — |
| 0 (this device) | K200178 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2020 | — |
| +1 | K211791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2021 | — |
| +2 | K222069 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2022 | — |
| +2 | K231757 | Ez3D-i /E3 | Ewoosoft Co., Ltd. | 2023 | — |
| +1 | K211700 | EzDent Web | Ewoosoft Co., Ltd. | 2021 | — |
| +2 | K230468 | EzDent Web | Ewoosoft Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K190791 | Ez3D-i/E3Summary page 5…aoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. 9. Predicate Device: • Ez3D-i /E3 (K190791) by Ewoosoft Co., Ltd. - Regulation number: 21 CFR 892.2050 - Regulation name: Picture archiving and communications s… | 2019 |
What descends from it? (8)
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?
- Its one ancestor has no recall.
- Of its descendants, K211791 (Ewoosoft Co., Ltd., 2021) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/K200178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200178: 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/K200178
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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