510(k) · Cleared
ClearedDBSWIN and VISTAEASY Imaging Software
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 Apr 1, 2019 as substantially equivalent to K161444 (Duerr Dental AG, 2016) after a 20-day review. Its family tree reaches back 6 generations to 1993. 5 later devices descend from it.
- Decided
- Apr 1, 2019
- Review
- 20 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930527 (1993). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK930527 Dental LinkEscan, Inc. · 1993
- 5 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 4 generations backK061035 Tigerview ProfessionalTelevere Systems · 2006
- 3 generations backK082623 Visix ImagingTelevere Systems · 2009
- 2 generations backK143290 DBSWIN and VistaEasy Imaging SoftwareDurr Dental AG · 2016
- 1 generation backK161444 DBSWIN and VistaEasy Imaging SoftwareDuerr Dental AG · 2016
- This deviceK190629 DBSWIN and VISTAEASY Imaging SoftwareDurr Dental SE · 2019
- Descendant · cites it directly · 3 of its ownK192743 VisionX 2.4Durr Dental SE · 2019
- Descendant · 2 generations on · 2 of its ownK213326 VisionX 3.0Durr Dental SE · 2021
- Descendant · 3 generations on · 1 of its ownK250947 VistaSoft 4.0 and VisionX 4.0Durr Dental SE · 2025
- Descendant · 4 generations on · 0 of its ownK253930 Overjet Iris Intelligent Imaging SystemOverjet, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK203287 Dbswin, VistaeasyDürr Dental SE · 2020
Most influential descendants
Showing 5 of 5 · See all- K192743VisionX 2.4Durr Dental SE · 2019 · cites it directly3descendants
- K213326VisionX 3.0Durr Dental SE · 2021 · 2 generations on2descendants
- K250947VistaSoft 4.0 and VisionX 4.0Durr Dental SE · 2025 · 3 generations on1descendant
- K253930Overjet Iris Intelligent Imaging SystemOverjet, Inc. · 2026 · 4 generations on0descendants
- K203287Dbswin, VistaeasyDürr Dental SE · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −5 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −4 | K061035 | Tigerview Professional | Televere Systems | 2006 | — |
| −3 | K082623 | Visix Imaging | Televere Systems | 2009 | — |
| −2 | K143290 | DBSWIN and VistaEasy Imaging Software | Durr Dental AG | 2016 | — |
| −1 | K161444 | DBSWIN and VistaEasy Imaging Software | Duerr Dental AG | 2016 | — |
| 0 (this device) | K190629 | DBSWIN and VISTAEASY Imaging Software | Durr Dental SE | 2019 | — |
| +1 | K192743 | VisionX 2.4 | Durr Dental SE | 2019 | — |
| +2 | K213326 | VisionX 3.0 | Durr Dental SE | 2021 | — |
| +3 | K250947 | VistaSoft 4.0 and VisionX 4.0 | Durr Dental SE | 2025 | — |
| +4 | K253930 | Overjet Iris Intelligent Imaging System | Overjet, Inc. | 2026 | — |
| +1 | K203287 | Dbswin, Vistaeasy | Dürr Dental SE | 2020 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K161444 | DBSWIN and VistaEasy Imaging SoftwareSummary page 5…= Device Class 2 4. Predicate Device: Legally Marketed Predicate Device Information: 510(k) Number: K161444 Manufacturer: "DÜRR DENTAL SE". Trade /Proprietary Name DBSWIN and VistaEasy Im… | 2016 |
What descends from it? (5)
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 26 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K192743 (Durr Dental SE, 2019) has gone furthest, with 3 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. 2019, 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?
DBSWIN and VistaEasy imaging software are intended for use by qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience. DBSWIN and VistaEasy are clinical software applications that receive images and data from various imaging sources (i.e., radiography devices and…
Read the full statement (155 words)
DBSWIN and VistaEasy imaging software are intended for use by qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience. DBSWIN and VistaEasy are clinical software applications that receive images and data from various imaging sources (i.e., radiography devices and digital video capture devices) that are manufactured and distributed by DÜRR Dental and Air Techniques. It is intended to acquire, display, edit (i.e., resize, adjust contrast, etc.) and distribute images using standard PC hardware. In addition, DBSWIN enables the acquisition of still images from 3rd party TWAIN compliant imaging devices (e.g., generic image devices such as scanners) and the storage and printing of clinical exam data, while VistaEasy distributes the acquired images to 3rd party TWAIN compliant PACS systems for storage and printing.
DBSWIN and VistaEasy software are not intended for mammography use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190629: DBSWIN and VISTAEASY Imaging Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190629
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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