510(k) · Cleared
ClearedActeon Imaging Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
De Gotzen S.R.L. · LLZ System, Image Processing, Radiological
Cleared on Feb 11, 2020 as substantially equivalent to K162799 (Palodex Group OY, 2017) and 1 other predicate after a 186-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Feb 11, 2020
- Review
- 186 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K954678 (1996). 27 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations between
- 3 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 2 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 1 generation backK162799 CliniviewPalodex Group OY · 2017
- This deviceK192165 Acteon Imaging SuiteDe Gotzen S.R.L. · 2020
Show all 9 generations
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 7 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 6 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 5 generations backK053155 VimplantCybermed, Inc. · 2005
- 4 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 3 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 2 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 1 generation backK162799 CliniviewPalodex Group OY · 2017
- This deviceK192165 Acteon Imaging SuiteDe Gotzen S.R.L. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −8 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −7 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −6 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −5 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −4 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −3 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −2 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| −1 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| 0 (this device) | K192165 | Acteon Imaging Suite | De Gotzen S.R.L. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K162799 | CliniviewSummary page 5…ion name Picture Archiving and Communication System Clearance date April, 25 2017 510(k) number K162799 Table 3: primary predicate device This predicate has not been subjected to a design-related recall. Acteon Imaging Suite 510… | 2017 |
| * | K171385 | Planmeca RomexisSummary page 6…gulation name Picture Archiving and Communication System Clearance date November, 14 2017 510(k) number K171385 Table 4: secondary predicate device This predicate has not been subjected to a design-related recall. No reference devices were… | 2017 |
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 24 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 27 ancestors have a recall of any class.
- 2 other devices also cite its predicate K162799.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Acteon Imaging Suite software program is indicated for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192165: Acteon Imaging Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192165
Report an extraction error
Are you the manufacturer?
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