510(k) · Cleared
ClearedCliniview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palodex Group OY · LLZ System, Image Processing, Radiological
Cleared on Apr 25, 2017 as substantially equivalent to K141451 (Imaging Sciences International (Dba Gendex, LLC), 2014) and 2 other predicates after a 202-day review. Its family tree reaches back 8 generations to 1996. 13 later devices descend from it.
- Decided
- Apr 25, 2017
- Review
- 202 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K954678 (1996). 25 ancestors in all, the oldest K924810 (1993). 13 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 6 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 5 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 4 generations backK053155 VimplantCybermed, Inc. · 2005
- 3 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 2 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 1 generation backK140713 Planmeca RomexisPlanmeca Oy · 2014
- This deviceK162799 CliniviewPalodex Group OY · 2017
- Descendant · cites it directly · 10 of its ownK203156 DTX Studio ClinicNobel Biocare AB · 2020
- Descendant · 2 generations on · 9 of its ownK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- Descendant · 3 generations on · 6 of its ownK233925 Relu CreatorRelu BV · 2024
- Descendant · 4 generations on · 3 of its ownK243989 Second Opinion® 3DPearl, Inc. · 2025
- Descendant · 4 generations on · 1 of its ownK260785 DS Core CBCT AnatomyDentsply Sirona · 2026
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K203156DTX Studio ClinicNobel Biocare AB · 2020 · cites it directly10descendants
- K213562DTX Studio Clinic 3.0Nobel Biocare AB · 2022 · 2 generations on9descendants
- K233925Relu CreatorRelu BV · 2024 · 3 generations on6descendants
- K243989Second Opinion® 3DPearl, Inc. · 2025 · 4 generations on3descendants
- K260785DS Core CBCT AnatomyDentsply Sirona · 2026 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −7 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −6 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −5 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −4 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −3 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −2 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −1 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| 0 (this device) | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| +1 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| +2 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| +3 | K233925 | Relu Creator | Relu BV | 2024 | — |
| +4 | K243989 | Second Opinion® 3D | Pearl, Inc. | 2025 | — |
| +4 | K260785 | DS Core CBCT Anatomy | Dentsply Sirona | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (3)
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 |
|---|---|---|---|
| * | K141451 | VixWin PlatinumSummary page 4…FR Number: 892.2050 Device Class: 2 Product Code: LLZ Predicate Device Proprietary Name: VixWin Platinum 510k Number: K141451 Common Name: Dental imaging device Classification Name: System, Image Processing, Radiological CFR Number:… | 2014 |
| * | K140445 | Dexis Software: Dexis Imaging Suite, Dexis MacSummary page 4…CFR Number: 892.2050 Device Class: 2 Product Code: LLZ Predicate Device Proprietary Name: DEXIS Software 510k Number: K140445 Common Name: Dental imaging device… | 2014 |
| * | K140713 | Planmeca RomexisSummary page 5…er: 892.2050 Device Class: 2 Product Code: LLZ Predicate Device Proprietary Name: Romexis 510k Number: K140713 Common Name: Dental imaging device Classification Name: System, Image Processing, Radiological CFR Number:… | 2014 |
What descends from it? (13)
See all 133 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?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K203156 (Nobel Biocare AB, 2020) has gone furthest, with 10 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. 2017, 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?
Cliniview software program is indicated for general dental and maxillofacial diagnostic imaging. It controls capture, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162799 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162799: Cliniview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162799
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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