510(k) · Cleared
ClearedOverjet Iris Intelligent Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Overjet, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Apr 10, 2026 as substantially equivalent to K250947 (Durr Dental SE, 2025) after a 122-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Apr 10, 2026
- Review
- 122 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K930527 (1993). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK930527 Dental LinkEscan, Inc. · 1993
- 6 generations between
- 3 generations backK192743 VisionX 2.4Durr Dental SE · 2019
- 2 generations backK213326 VisionX 3.0Durr Dental SE · 2021
- 1 generation backK250947 VistaSoft 4.0 and VisionX 4.0Durr Dental SE · 2025
- This deviceK253930 Overjet Iris Intelligent Imaging SystemOverjet, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK930527 Dental LinkEscan, Inc. · 1993
- 9 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 8 generations backK061035 Tigerview ProfessionalTelevere Systems · 2006
- 7 generations backK082623 Visix ImagingTelevere Systems · 2009
- 6 generations backK143290 DBSWIN and VistaEasy Imaging SoftwareDurr Dental AG · 2016
- 5 generations backK161444 DBSWIN and VistaEasy Imaging SoftwareDuerr Dental AG · 2016
- 4 generations backK190629 DBSWIN and VISTAEASY Imaging SoftwareDurr Dental SE · 2019
- 3 generations backK192743 VisionX 2.4Durr Dental SE · 2019
- 2 generations backK213326 VisionX 3.0Durr Dental SE · 2021
- 1 generation backK250947 VistaSoft 4.0 and VisionX 4.0Durr Dental SE · 2025
- This deviceK253930 Overjet Iris Intelligent Imaging SystemOverjet, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −9 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −8 | K061035 | Tigerview Professional | Televere Systems | 2006 | — |
| −7 | K082623 | Visix Imaging | Televere Systems | 2009 | — |
| −6 | K143290 | DBSWIN and VistaEasy Imaging Software | Durr Dental AG | 2016 | — |
| −5 | K161444 | DBSWIN and VistaEasy Imaging Software | Duerr Dental AG | 2016 | — |
| −4 | K190629 | DBSWIN and VISTAEASY Imaging Software | Durr Dental SE | 2019 | — |
| −3 | K192743 | VisionX 2.4 | Durr Dental SE | 2019 | — |
| −2 | K213326 | VisionX 3.0 | Durr Dental SE | 2021 | — |
| −1 | K250947 | VistaSoft 4.0 and VisionX 4.0 | Durr Dental SE | 2025 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K250947 | VistaSoft 4.0 and VisionX 4.0Summary page 6…Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II 510(k) : K250947 Product code: QIH 9. Indications for Use Comparison: The indications for Use for Iris Intelligent System is determined to… | 2025 |
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 33 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- None of the 11 ancestors has a recall.
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. 2026, 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?
Overjet Iris Intelligent Imaging System is a web-based dental image management software (Picture Archiving and Communication System, PACS). The system enables acquisition, cloud-based storage, archival, display, and distribution of digital dental images. Images can be acquired from dental image acquisition devices (intraoral sensors or extraoral panoramic machines) and/or consumer imaging devices such as color digital cameras. In addition, the system…
Read the full statement (140 words)
Overjet Iris Intelligent Imaging System is a web-based dental image management software (Picture Archiving and Communication System, PACS). The system enables acquisition, cloud-based storage, archival, display, and distribution of digital dental images. Images can be acquired from dental image acquisition devices (intraoral sensors or extraoral panoramic machines) and/or consumer imaging devices such as color digital cameras.
In addition, the system provides automated identification and reporting of image capture quality issues, including the presence of intraoperative tools within the field of view, cone cut, overlapping interproximal contacts, inadequate crestal bone coverage, inadequate apical coverage, inadequate coronal coverage, foreshortening, and elongation. These image quality indicators are intended to assist clinicians in evaluating the adequacy of intraoral radiographs but are not a substitute for professional clinical judgment.
The device is intended to provide images for review and diagnostic use by trained dental professionals
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253930 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253930: Overjet Iris Intelligent Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253930
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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