510(k) · Cleared
ClearedImage One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infomed Software, S.L. · LLZ System, Image Processing, Radiological
Cleared on Jul 23, 2025 as substantially equivalent to K230468 (Ewoosoft Co., Ltd., 2023) after a 135-day review. Its family tree reaches back 14 generations to 1993.
- Decided
- Jul 23, 2025
- Review
- 135 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K930527 (1993). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK930527 Dental LinkEscan, Inc. · 1993
- 10 generations between
- 3 generations backK202116 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2020
- 2 generations backK211700 EzDent WebEwoosoft Co., Ltd. · 2021
- 1 generation backK230468 EzDent WebEwoosoft Co., Ltd. · 2023
- This deviceK250716 Image OneInfomed Software, S.L. · 2025
Show all 14 generations
- Root · 14 generations backK930527 Dental LinkEscan, Inc. · 1993
- 13 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 12 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 11 generations backK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- 10 generations backK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
- 9 generations backK131594 Ezdenti-I; E2; Prora ViewEwoosoft Co., Ltd. · 2013
- 8 generations backK150747 EzDent-i /E2/Prora ViewLK Consulting Group USA, Inc. · 2015
- 7 generations backK161117 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2016
- 6 generations backK163533 EzDent-i; E2; ProraViewEwoosoft Co., Ltd. · 2017
- 5 generations backK172364 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2017
- 4 generations backK190087 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2019
- 3 generations backK202116 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2020
- 2 generations backK211700 EzDent WebEwoosoft Co., Ltd. · 2021
- 1 generation backK230468 EzDent WebEwoosoft Co., Ltd. · 2023
- This deviceK250716 Image OneInfomed Software, S.L. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −13 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −12 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −11 | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| −10 | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | 1 |
| −9 | K131594 | Ezdenti-I; E2; Prora View | Ewoosoft Co., Ltd. | 2013 | — |
| −8 | K150747 | EzDent-i /E2/Prora View | LK Consulting Group USA, Inc. | 2015 | — |
| −7 | K161117 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2016 | — |
| −6 | K163533 | EzDent-i; E2; ProraView | Ewoosoft Co., Ltd. | 2017 | — |
| −5 | K172364 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2017 | — |
| −4 | K190087 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2019 | — |
| −3 | K202116 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2020 | — |
| −2 | K211700 | EzDent Web | Ewoosoft Co., Ltd. | 2021 | — |
| −1 | K230468 | EzDent Web | Ewoosoft Co., Ltd. | 2023 | — |
| 0 (this device) | K250716 | Image One | Infomed Software, S.L. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K230468 | EzDent WebSummary page 5…892.2050 Product Code LLZ III) Predicate Device 510(k) Number K230468 Applicant Ewoosoft Co., Ltd. Trade Name Ez… | 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 32 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 16 ancestors has a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
IMAGE ONE is a dental imaging software that is intended to provide viewer and image processing tools for maxillofacial radiographic images. 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.
IMAGE ONE is intended for use as software to acquire, view, and save 2D and 3D image files, to load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment, and to provide 3D visualization and 2D analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250716: Image One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250716
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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