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 Jan 24, 2024 as substantially equivalent to K221511 (Axial Medical Printing Limited, 2022) after a 237-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jan 24, 2024
- Review
- 237 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924630 (1993). 7 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK073468 MimicsMaterialise NV · 2008
- 2 generations backK173619 Mimics inPrintMaterialise NV · 2018
- 1 generation backK221511 Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 2022
- This deviceK231607 Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K073468 | Mimics | Materialise NV | 2008 | — |
| −2 | K173619 | Mimics inPrint | Materialise NV | 2018 | — |
| −1 | K221511 | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K221511 | Axial3D Cloud Segmentation ServiceSummary page 4…Manufacturer 510(k)# Axial Medical Printing Axial3D K221511 Limited… | 2022 |
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 31 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K221511.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Framework for the transfer of DICOM imaging information from a medical scanner to an output file, which 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 and/or diagnostic purposes in the field of orthopedic, maxillofacial…
Read the full statement (115 words)
Axial3D Cloud Segmentation Service is intended for use as a cloud-based service and image segmentation Framework for the transfer of DICOM imaging information from a medical scanner to an output file, which 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 and/or diagnostic purposes in the field of orthopedic, maxillofacial, and cardiovascular applications in adults. The output file or physical replica may also be used for pediatrics between the ages of 12 and 21 years of age in cardiovascular applications.
Axial3D Cloud Segmentation Service should be used with other diagnostic tools and expert clinical judgment.
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/K231607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K231607: Axial3D Cloud Segmentation Service.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K231607
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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