510(k) · Cleared
Recalled · 2011Codiagnostix (R) 5.72
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivs Solutions AG · LLZ System, Image Processing, Radiological
Cleared on Aug 9, 2007 as substantially equivalent to K033849 (Materialise NV, 2004) and 1 other predicate after a 55-day review. Its family tree reaches back 5 generations to 1996. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 9, 2007
- Review
- 55 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954678 (1996). 9 ancestors in all, the oldest K924810 (1993). 21 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 1 generation backK053155 VimplantCybermed, Inc. · 2005
- This deviceK071636 Codiagnostix (R) 5.72Ivs Solutions AG · 2007
- Descendant · cites it directly · 15 of its ownK130724 Codiagnostix Implant Planning SoftwareStraumann USA · 2013
- Descendant · 2 generations on · 8 of its ownK141570 Implant Studio3Shape Medical A/S · 2014
- Descendant · 2 generations on · 7 of its ownK152078 Implant Studio 20153Shape Medical A/S · 2015
- Descendant · cites it directly · 4 of its ownK112251 Swissmeda Dental Planning SystemSwissmeda AG · 2012
- Descendant · 2 generations on · 3 of its ownK123976 NobelclinicianNobel Biocare AB · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K130724Codiagnostix Implant Planning SoftwareStraumann USA · 2013 · cites it directly15descendants
- K141570Implant Studio3Shape Medical A/S · 2014 · 2 generations on8descendants
- K152078Implant Studio 20153Shape Medical A/S · 2015 · 2 generations on7descendants
- K112251Swissmeda Dental Planning SystemSwissmeda AG · 2012 · cites it directly4descendants
- K123976NobelclinicianNobel Biocare AB · 2013 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −1 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| 0 (this device) | K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | 2007 | — |
| +1 | K130724 | Codiagnostix Implant Planning Software | Straumann USA | 2013 | — |
| +2 | K141570 | Implant Studio | 3Shape Medical A/S | 2014 | — |
| +2 | K152078 | Implant Studio 2015 | 3Shape Medical A/S | 2015 | — |
| +1 | K112251 | Swissmeda Dental Planning System | Swissmeda AG | 2012 | — |
| +2 | K123976 | Nobelclinician | Nobel Biocare AB | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K033849 | Simplant SystemSummary page 1…CyberMed, Inc. Trade Name SimPlant System VimplantTm 510(k) Number K033849 K053 155 Regulation Number 892.2050 892.2050 rProd u… | 2004 |
| * | K053155 | VimplantSummary page 1…ade Name SimPlant System VimplantTm 510(k) Number K033849 K053 155 Regulation Number 892.2050 892.2050 rProd uct Co deu… | 2005 |
What descends from it? (21)
See all 212 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 4, 2011 | Not classified | Z-3184-2011 | Software design | Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed. |
| Sep 30, 2010 | Not classified | Z-1592-2011 | Software design | Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K130724 (Straumann USA, 2013) has gone furthest, with 15 descendants of its own.
- 19 other devices also cite its predicate K033849.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
coDiagnostiX® is intended for use by medical trained people as a Windows®- based diagnosis and implant planning software. This software is an interface for the transfer of imaging information from medical scanners such as CT or DVT scanners and also a pre- operative software for simulation and evaluation dental implant placement and surgical treatment options. The patient population will be the general public. coDiagnostiX® is not intended to be used in…
Read the full statement (133 words)
coDiagnostiX® is intended for use by medical trained people as a Windows®- based diagnosis and
implant planning software.
This software is an interface for the transfer of imaging information from medical scanners such as CT or
DVT scanners and also a pre- operative software for simulation and evaluation dental implant placement
and surgical treatment options.
The patient population will be the general public.
coDiagnostiX® is not intended to be used in direct contact with the patient nor is it intended to be used
with life sustaining devices.
It's possible to use coDiagnostiX® as a pattern for manufacturing drilling templates with conventional
rotary tables or the gonyX® table from IVS Solutions AG in laboratory environment. This drilling template
is then used in direct contact with the patient to realize the implant planning with coDiagnostiX®.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071636: Codiagnostix (R) 5.72.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071636
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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