510(k) · Cleared
ClearedDexis Software: Dexis Imaging Suite, Dexis Mac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Sciences International, LLC · LLZ System, Image Processing, Radiological
Cleared on Apr 23, 2014 after a 61-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.
- Decided
- Apr 23, 2014
- Review
- 61 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK140445 Dexis Software: Dexis Imaging Suite, Dexis MacImaging Sciences International, LLC · 2014
- Descendant · cites it directly · 13 of its ownK162799 CliniviewPalodex Group OY · 2017
- Descendant · 2 generations on · 10 of its ownK203156 DTX Studio ClinicNobel Biocare AB · 2020
- Descendant · 3 generations on · 9 of its ownK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- Descendant · 4 generations on · 6 of its ownK233925 Relu CreatorRelu BV · 2024
- Descendant · 5 generations on · 3 of its ownK243989 Second Opinion® 3DPearl, Inc. · 2025
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K162799CliniviewPalodex Group OY · 2017 · cites it directly13descendants
- K203156DTX Studio ClinicNobel Biocare AB · 2020 · 2 generations on10descendants
- K213562DTX Studio Clinic 3.0Nobel Biocare AB · 2022 · 3 generations on9descendants
- K233925Relu CreatorRelu BV · 2024 · 4 generations on6descendants
- K243989Second Opinion® 3DPearl, Inc. · 2025 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140445 | Dexis Software: Dexis Imaging Suite, Dexis Mac | Imaging Sciences International, LLC | 2014 | — |
| +1 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| +2 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| +3 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| +4 | K233925 | Relu Creator | Relu BV | 2024 | — |
| +5 | K243989 | Second Opinion® 3D | Pearl, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (15)
See all 152 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?
- Of its descendants, K162799 (Palodex Group OY, 2017) has gone furthest, with 13 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. 2014, 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 valor images from intra-oral and extra-oral dental cameras.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K140445 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140445: Dexis Software: Dexis Imaging Suite, Dexis Mac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140445
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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