510(k) · Cleared
ClearedAxial3D Insight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axial Medical Printing Limited · QIH Automated Radiological Image Processing Software
Cleared on Nov 15, 2023 as substantially equivalent to K222745 (Axial Medical Printing Limited, 2023) after a 62-day review. Its family tree reaches back 7 generations to 1993. 1 later device descends from it.
- Decided
- Nov 15, 2023
- Review
- 62 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K924630 (1993). 8 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 5 generations backK033849 Simplant SystemMaterialise NV · 2004
- 4 generations backK073468 MimicsMaterialise NV · 2008
- 3 generations backK173619 Mimics inPrintMaterialise NV · 2018
- 2 generations backK221511 Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 2022
- 1 generation backK222745 Axial3D InsightAxial Medical Printing Limited · 2023
- This deviceK232841 Axial3D InsightAxial Medical Printing Limited · 2023
- Descendant · cites it directly · 0 of its ownK250369 Axial3D InsightAxial Medical Printing Limited · 2025
Most influential descendants
Showing 1 of 1 · See all- K250369Axial3D InsightAxial Medical Printing Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −6 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −5 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −4 | K073468 | Mimics | Materialise NV | 2008 | — |
| −3 | K173619 | Mimics inPrint | Materialise NV | 2018 | — |
| −2 | K221511 | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | 2022 | — |
| −1 | K222745 | Axial3D Insight | Axial Medical Printing Limited | 2023 | — |
| 0 (this device) | K232841 | Axial3D Insight | Axial Medical Printing Limited | 2023 | — |
| +1 | K250369 | Axial3D Insight | Axial Medical Printing Limited | 2025 | — |
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 |
|---|---|---|
| 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K222745 | Axial3D InsightSummary page 6…Name Manufacturer 510(k)# Axial3D Insight Axial Medical Printing Limited K222745 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. 5.4 Devi… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250369 | Axial3D Insight | 2025 | 0 |
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 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K250369 (Axial Medical Printing Limited, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
Axial3D Insight 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.
The Axial3D Insight 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 output file or physical replica can be used for diagnostic purposes in the field of trauma, orthopedic, maxillofacial, and cardiovascular applications.
Axial3D Insight 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/K232841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232841: Axial3D Insight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232841
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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