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 Sep 18, 2025 as substantially equivalent to K232841 (Axial Medical Printing Limited, 2023) after a 220-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Sep 18, 2025
- Review
- 220 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K924630 (1993). 9 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 8 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 7 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 6 generations backK033849 Simplant SystemMaterialise NV · 2004
- 5 generations backK073468 MimicsMaterialise NV · 2008
- 4 generations backK173619 Mimics inPrintMaterialise NV · 2018
- 3 generations backK221511 Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 2022
- 2 generations backK222745 Axial3D InsightAxial Medical Printing Limited · 2023
- 1 generation backK232841 Axial3D InsightAxial Medical Printing Limited · 2023
- This deviceK250369 Axial3D InsightAxial Medical Printing Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −7 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −6 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −5 | K073468 | Mimics | Materialise NV | 2008 | — |
| −4 | K173619 | Mimics inPrint | Materialise NV | 2018 | — |
| −3 | K221511 | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | 2022 | — |
| −2 | K222745 | Axial3D Insight | Axial Medical Printing Limited | 2023 | — |
| −1 | K232841 | Axial3D Insight | Axial Medical Printing Limited | 2023 | — |
| 0 (this device) | K250369 | Axial3D Insight | Axial Medical Printing Limited | 2025 | — |
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 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 |
|---|---|---|---|
| * | K232841 | Axial3D InsightSummary page 5…Name Manufacturer 510(k)# Axial3D Insight Axial Medical Printing Limited K232841 K250369… | 2023 |
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 32 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 9 ancestors has a recall.
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. 2025, 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 the physical replica can be used for diagnostic purposes in the field of trauma, orthopedic, maxillofacial and cardiovascular applications. Axial3D Insight 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/K250369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250369: 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/K250369
Report an extraction error
Are you the manufacturer?
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