510(k) · Cleared
ClearedARTICOR planner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artiness S.R.L · LLZ System, Image Processing, Radiological
Cleared on Mar 27, 2026 as substantially equivalent to K190874 (Materialise NV, 2019) after a 256-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Mar 27, 2026
- Review
- 256 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954678 (1996). 27 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 backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 4 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 3 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 2 generations backK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- 1 generation backK190874 Materialise Mimics EnlightMaterialise NV · 2019
- This deviceK252195 ARTICOR plannerArtiness S.R.L · 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 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −4 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −3 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −2 | K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 | 1 |
| −1 | K190874 | Materialise Mimics Enlight | Materialise NV | 2019 | — |
| 0 (this device) | K252195 | ARTICOR planner | Artiness S.R.L | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K190874 | Materialise Mimics EnlightSummary page 6…LLZ, System, Image Processing, Radiological Device Class: Class II Classification Panel: Radiology 5. Legally Marketed Predicate Device K190874, Device: Materialise Mimics Enlight, Manufacturer: Materialise N.V. 6. Indications for Use Statement ARTICOR planner is inte… | 2019 |
| † | K220649 | Elucis | 2023 |
| † | K101342 | Osirix MD | 2010 |
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 4.1 years on median.
- 5 of the 27 ancestors have a recall of any class.
- 1 other device also cites its predicate K190874.
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?
ARTICOR planner is intended for use as a software interface and image segmentation system to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, ARTICOR planner provides additional visualization and measurement tools to enable the user to screen and plan the procedure.
ARTICOR planner should be used in conjunction with other diagnostic tools and expert clinical judgement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252195: ARTICOR planner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252195
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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