510(k) · Cleared
ClearedVisionX 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Durr Dental SE · LLZ System, Image Processing, Radiological
Cleared on Nov 2, 2021 as substantially equivalent to K192743 (Durr Dental SE, 2019) after a 28-day review. Its family tree reaches back 8 generations to 1993. 2 later devices descend from it.
- Decided
- Nov 2, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K930527 (1993). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK930527 Dental LinkEscan, Inc. · 1993
- 7 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 6 generations backK061035 Tigerview ProfessionalTelevere Systems · 2006
- 5 generations backK082623 Visix ImagingTelevere Systems · 2009
- 4 generations backK143290 DBSWIN and VistaEasy Imaging SoftwareDurr Dental AG · 2016
- 3 generations backK161444 DBSWIN and VistaEasy Imaging SoftwareDuerr Dental AG · 2016
- 2 generations backK190629 DBSWIN and VISTAEASY Imaging SoftwareDurr Dental SE · 2019
- 1 generation backK192743 VisionX 2.4Durr Dental SE · 2019
- This deviceK213326 VisionX 3.0Durr Dental SE · 2021
- Descendant · cites it directly · 1 of its ownK250947 VistaSoft 4.0 and VisionX 4.0Durr Dental SE · 2025
- Descendant · 2 generations on · 0 of its ownK253930 Overjet Iris Intelligent Imaging SystemOverjet, Inc. · 2026
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 |
|---|---|---|---|---|---|
| −8 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −7 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −6 | K061035 | Tigerview Professional | Televere Systems | 2006 | — |
| −5 | K082623 | Visix Imaging | Televere Systems | 2009 | — |
| −4 | K143290 | DBSWIN and VistaEasy Imaging Software | Durr Dental AG | 2016 | — |
| −3 | K161444 | DBSWIN and VistaEasy Imaging Software | Duerr Dental AG | 2016 | — |
| −2 | K190629 | DBSWIN and VISTAEASY Imaging Software | Durr Dental SE | 2019 | — |
| −1 | K192743 | VisionX 2.4 | Durr Dental SE | 2019 | — |
| 0 (this device) | K213326 | VisionX 3.0 | Durr Dental SE | 2021 | — |
| +1 | K250947 | VistaSoft 4.0 and VisionX 4.0 | Durr Dental SE | 2025 | — |
| +2 | K253930 | Overjet Iris Intelligent Imaging System | Overjet, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K192743 | VisionX 2.4Summary page 4…2050 Device Class 2 3. Predicate Device: Legally Marketed Predicate Device Information: 510(k) Number: K192743 Manufacturer: DÜRR DENTAL SE Trade /Proprietary Name VisionX 2.4… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250947 | VistaSoft 4.0 and VisionX 4.0 | 2025 | 1 |
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 28 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K250947 (Durr Dental SE, 2025) has gone furthest, with 1 descendant 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. 2021, 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?
The software is intended for the viewing and diagnosis of image data in relation to dental issues. Its proper use is documented in the operating instructions of the corresponding image-generating systems. Image-generating systems that can be used with the software include optical video cameras, digital X-ray cameras, image plate scanners, extraoral X-ray devices, intraoral scanners and TWAIN compatible image sources. The software must only be used by…
Read the full statement (129 words)
The software is intended for the viewing and diagnosis of image data in relation to dental issues. Its proper use is documented in the operating instructions of the corresponding image-generating systems. Image-generating systems that can be used with the software include optical video cameras, digital X-ray cameras, image plate scanners, extraoral X-ray devices, intraoral scanners and TWAIN compatible image sources.
The software must only be used by authorized healthcare professionals in dental areas for the following tasks:
- Filter optimisation of the display of 2D and 3D images for improved diagnosis
- Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitised 2D and 3D images and videos
- Forwarding of images and additional data to external software (third-party software)
The software is not intended for mammography use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213326 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213326: VisionX 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213326
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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