510(k) · Cleared
ClearedMaterialise Mimics Enlight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · LLZ System, Image Processing, Radiological
Cleared on Jun 5, 2019 as substantially equivalent to K183105 (Materialise NV, 2019) and 2 other predicates after a 62-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it.
- Decided
- Jun 5, 2019
- Review
- 62 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K954678 (1996). 26 ancestors in all, the oldest K924810 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 3 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 2 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 1 generation backK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- This deviceK190874 Materialise Mimics EnlightMaterialise NV · 2019
- Descendant · cites it directly · 0 of its ownK252195 ARTICOR plannerArtiness S.R.L · 2026
- Descendant · cites it directly · 0 of its ownK233217 Mimics Cardiac PlannerMaterialise NV · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −3 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −2 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −1 | K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 | 1 |
| 0 (this device) | K190874 | Materialise Mimics Enlight | Materialise NV | 2019 | — |
| +1 | K252195 | ARTICOR planner | Artiness S.R.L | 2026 | — |
| +1 | K233217 | Mimics Cardiac Planner | Materialise NV | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 21.6 · 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 |
|---|---|---|---|
| * | K183105 | Mimics MedicalSummary page 6…Page 2 of 5 Trade or proprietary or model name Mimics Medical 510(k) number K183105 Decision date March 27, 2019 Classification product code… | 2019 |
| * | K153736 | 3mensio WorkstationSummary page 6…t to a design-related recall: Trade or proprietary or model name 3mensio Workstation 510(k) number K153736 Decision date May 27, 2016 Classification product code… | 2016 |
| * | K173619 | Mimics inPrintSummary page 6…Medical Imaging B.V. The other reference predicate device to which substantial equivalence is claimed, which has been cleared for marketing in the United States (under K173619) and which has not been subject to a design-related recall: Trade or proprietary or model name Mimics i… | 2018 |
What descends from it? (2)
2 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 23 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K252195 (Artiness S.R.L, 2026) has gone furthest, with 0 descendants of its own.
- 16 other devices also cite its predicate K183105.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Materialise Mimics Enlight is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as a software to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, Materialise Mimics Enlight provides additional visualisation and measurement tools to enable the user to…
Read the full statement (130 words)
Materialise Mimics Enlight is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file.
It is also intended as a software to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, Materialise Mimics Enlight provides additional visualisation and measurement tools to enable the user to screen and plan the procedure.
The Materialise Mimics Enlight output file can be used for the fabrication of physical replicas of the output file using traditional additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of cardiovascular applications.
Materialise Mimics Enlight should be used in conjunction with other diagnostic tools and expert clinical judgement.
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/K190874 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190874: Materialise Mimics Enlight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190874
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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