510(k) · Cleared
ClearedClio/Cliosoft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sota Precision Optics, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jun 30, 2011 as substantially equivalent to K060178 (Gendex Dental Systems, 2006) and 1 other predicate after a 92-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Jun 30, 2011
- Review
- 92 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K930527 (1993). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK110886 Clio/CliosoftSota Precision Optics, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK241495 Jazz ClassicJazz Imaging · 2024
Most influential descendants
Showing 1 of 1 · See all- K241495Jazz ClassicJazz Imaging · 2024 · cites it directly0descendants
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) | K110886 | Clio/Cliosoft | Sota Precision Optics, Inc. | 2011 | — |
| +1 | K241495 | Jazz Classic | Jazz Imaging | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K060178 | Vix Win ProSummary page 1…Product Code: MUH and LIZ Regulation: 21 CFR 892.1800 and 21 CFR 892.2050, Class II 510(k) Number: K060178 Manufacturer: TOSHIBA AMERICA ELECTRONIC COMPONENTS, INC. Product Name: Digi… | 2006 |
| * | K092537 | Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Summary page 1…igital X-ray Sensor Product Code: MUH Regulation: 21 CFR 892.1800, Class 11 510(k) Number: K092537 SOTA IMAGING Page 23 of 769 OLIO/CLIOSOFT… | 2009 |
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 |
|---|---|---|---|
| K241495 | Jazz Classic | 2024 | 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 18 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K241495 (Jazz Imaging, 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K060178.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
CLIOSOFT is a clinical software application that receives images and data from CLIO sensor and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, CLIOSOFT enables the storage of clinical notes and clinical exam data.
It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute images using standard PC hardware.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110886: Clio/Cliosoft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110886
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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