510(k) · Cleared
ClearedVistaSoft 4.0 and VisionX 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Durr Dental SE · QIH Automated Radiological Image Processing Software
Cleared on Aug 27, 2025 as substantially equivalent to K213326 (Durr Dental SE, 2021) after a 152-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.
- Decided
- Aug 27, 2025
- Review
- 152 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K930527 (1993). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK930527 Dental LinkEscan, Inc. · 1993
- 5 generations between
- 3 generations backK190629 DBSWIN and VISTAEASY Imaging SoftwareDurr Dental SE · 2019
- 2 generations backK192743 VisionX 2.4Durr Dental SE · 2019
- 1 generation backK213326 VisionX 3.0Durr Dental SE · 2021
- This deviceK250947 VistaSoft 4.0 and VisionX 4.0Durr Dental SE · 2025
- Descendant · cites it directly · 0 of its ownK253930 Overjet Iris Intelligent Imaging SystemOverjet, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK930527 Dental LinkEscan, Inc. · 1993
- 8 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 7 generations backK061035 Tigerview ProfessionalTelevere Systems · 2006
- 6 generations backK082623 Visix ImagingTelevere Systems · 2009
- 5 generations backK143290 DBSWIN and VistaEasy Imaging SoftwareDurr Dental AG · 2016
- 4 generations backK161444 DBSWIN and VistaEasy Imaging SoftwareDuerr Dental AG · 2016
- 3 generations backK190629 DBSWIN and VISTAEASY Imaging SoftwareDurr Dental SE · 2019
- 2 generations backK192743 VisionX 2.4Durr Dental SE · 2019
- 1 generation backK213326 VisionX 3.0Durr Dental SE · 2021
- This deviceK250947 VistaSoft 4.0 and VisionX 4.0Durr Dental SE · 2025
Most influential descendants
Showing 1 of 1 · See all- K253930Overjet Iris Intelligent Imaging SystemOverjet, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −8 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −7 | K061035 | Tigerview Professional | Televere Systems | 2006 | — |
| −6 | K082623 | Visix Imaging | Televere Systems | 2009 | — |
| −5 | K143290 | DBSWIN and VistaEasy Imaging Software | Durr Dental AG | 2016 | — |
| −4 | K161444 | DBSWIN and VistaEasy Imaging Software | Duerr Dental AG | 2016 | — |
| −3 | K190629 | DBSWIN and VISTAEASY Imaging Software | Durr Dental SE | 2019 | — |
| −2 | K192743 | VisionX 2.4 | Durr Dental SE | 2019 | — |
| −1 | K213326 | VisionX 3.0 | Durr Dental SE | 2021 | — |
| 0 (this device) | K250947 | VistaSoft 4.0 and VisionX 4.0 | Durr Dental SE | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K213326 | VisionX 3.0Summary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code 1 K213326 1 1 VisionX 3.0 ,_ Device Description Summary… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253930 | Overjet Iris Intelligent Imaging System | 2026 | 0 |
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 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K253930 (Overjet, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
VistaSoft 4.0 and VisionX 4.0 imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. VisionX 4.0 / VistaSoft 4.0 runs on user provided PC compatible computers and utilize previously cleared digital image capture devices for image acquisition. The software must only be used by authorized healthcare professionals in dental areas for the following tasks: - Filter…
Read the full statement (118 words)
VistaSoft 4.0 and VisionX 4.0 imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. VisionX 4.0 / VistaSoft 4.0 runs on user provided PC compatible computers and utilize previously cleared digital image capture devices for image acquisition.
The software must only be used by authorized healthcare professionals in dental areas for the following tasks:
- Filter optimization 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/K250947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250947: VistaSoft 4.0 and VisionX 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250947
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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