510(k) · Cleared
ClearedNeowise
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cefla S.C. · LLZ System, Image Processing, Radiological
Cleared on May 4, 2026 as substantially equivalent to K200572 (Planmeca Oy, 2020) after a 60-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- May 4, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954678 (1996). 16 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- 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 backK200572 Planmeca RomexisPlanmeca Oy · 2020
- This deviceK260716 NeowiseCefla S.C. · 2026
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 | K200572 | Planmeca Romexis | Planmeca Oy | 2020 | — |
| 0 (this device) | K260716 | Neowise | Cefla S.C. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K200572 | Planmeca RomexisSummary page 6…Applicant/Manufacturer: Planmeca Oy Asentajankatu 6 Helsinki, 00880 FINLAND 510 (k): K200572 Identification CEFLA S.C. will refer to the following reference device: of Reference Device: Proprietary Name: D… | 2020 |
| † | K203156 | DTX Studio Clinic | 2020 |
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 30 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K200572.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Neowise is a medical imaging software intended for use in dental and medical applications as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to elaborate (retrieve, process, render, diagnose, review, and for non-medical application as store, print and…
Read the full statement (131 words)
Neowise is a medical imaging software intended for use in dental and medical applications as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to elaborate (retrieve, process, render, diagnose, review, and for non-medical application as store, print and distribute) images of both adults and pediatric patients.
Neowise is also software for simulating treatment options.
Neowise is also intended to be used for monitoring, recording, storing and displaying mandibular jaw position related to maxilla.
The software is for use by authorized healthcare professionals. Use of the software for surgical treatment planning requires that the user has the necessary medical training in maxillofacial surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260716 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260716: Neowise.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260716
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026