510(k) · Cleared
ClearedAxial3D Cloud Segmentation Service
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axial Medical Printing Limited · LLZ System, Image Processing, Radiological
Cleared on Jun 23, 2022 as substantially equivalent to K173619 (Materialise NV, 2018) after a 30-day review. Its family tree reaches back 5 generations to 1993. 4 later devices descend from it.
- Decided
- Jun 23, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924630 (1993). 6 ancestors in all, the oldest K924810 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 4 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 3 generations backK033849 Simplant SystemMaterialise NV · 2004
- 2 generations backK073468 MimicsMaterialise NV · 2008
- 1 generation backK173619 Mimics inPrintMaterialise NV · 2018
- This deviceK221511 Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 2022
- Descendant · cites it directly · 2 of its ownK222745 Axial3D InsightAxial Medical Printing Limited · 2023
- Descendant · 2 generations on · 1 of its ownK232841 Axial3D InsightAxial Medical Printing Limited · 2023
- Descendant · 3 generations on · 0 of its ownK250369 Axial3D InsightAxial Medical Printing Limited · 2025
- Descendant · cites it directly · 0 of its ownK231607 Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 2024
Most influential descendants
Showing 4 of 4 · See all- K222745Axial3D InsightAxial Medical Printing Limited · 2023 · cites it directly2descendants
- K232841Axial3D InsightAxial Medical Printing Limited · 2023 · 2 generations on1descendant
- K250369Axial3D InsightAxial Medical Printing Limited · 2025 · 3 generations on0descendants
- K231607Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −4 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −3 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −2 | K073468 | Mimics | Materialise NV | 2008 | — |
| −1 | K173619 | Mimics inPrint | Materialise NV | 2018 | — |
| 0 (this device) | K221511 | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | 2022 | — |
| +1 | K222745 | Axial3D Insight | Axial Medical Printing Limited | 2023 | — |
| +2 | K232841 | Axial3D Insight | Axial Medical Printing Limited | 2023 | — |
| +3 | K250369 | Axial3D Insight | Axial Medical Printing Limited | 2025 | — |
| +1 | K231607 | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K173619 | Mimics inPrintSummary page 5…Classification Name: System, Image Processing, Radiological (21CFR 892.2050, Product Code LLZ) 510(k) Number: K173619 Device Description Axial3D Cloud Segmentation Service is a secure, highly available cloud based image processing, segmentatio… | 2018 |
What descends from it? (4)
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 29 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K222745 (Axial Medical Printing Limited, 2023) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K173619.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Axial3D Cloud Segmentation Service is intended for use as a cloud based service and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file.
The Axial3D Cloud Segmentation Service output file can be used for the fabrication of physical replicas of the output file using additive manufacturing methods.
The output file or physical replica can be used for treatment planning.
The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications.
Axial3D Cloud Segmentation Service should be used in conjunction with other diagnostic tools and expert clinical judgment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221511: Axial3D Cloud Segmentation Service.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221511
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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