510(k) · Cleared
ClearedDexis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dexis, LLC · LLZ System, Image Processing, Radiological
Cleared on Jun 22, 2009 as substantially equivalent to K962631 (Fair Image, Inc., 1996) and 1 other predicate after a 123-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Jun 22, 2009
- Review
- 123 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K930527 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK930527 Dental LinkEscan, Inc. · 1993
- 4 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 3 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 2 generations backK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- 1 generation backK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
- This deviceK090431 Dexis SoftwareDexis, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −4 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −3 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −2 | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| −1 | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | 1 |
| 0 (this device) | K090431 | Dexis Software | Dexis, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (2)
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 |
|---|---|---|---|
| * | K962631 | Dexis Model 601 Dental Electronic Imaging SystemSummary page 1…unication Systems, per 21 CFR § 892.2050. Devices for Which Substantial Equivalence is Claimed: * Fair Image, Inc., (now owned by DEXIS, LLC.), DEXIS Model 601 (K962631) . Gendex Dental Systems, Vix Win Pro (K0601 78) Device Description: The DEXIS Software is a software program for general den… | 1996 |
| * | K060178 | Vix Win ProSummary page 1…evices for Which Substantial Equivalence is Claimed: * Fair Image, Inc., (now owned by DEXIS, LLC.), DEXIS Model 601 (K962631) . Gendex Dental Systems, Vix Win Pro (K0601 78) Device Description: The DEXIS Software is a software program for general dental and maxillo-facial diagnostic imaging. It cont… | 2006 |
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 16 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 6 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. 2009, 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 DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital images from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090431 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090431: Dexis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090431
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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