510(k) · Cleared
ClearedSMART Bun-Yo-Matic CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disior, Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Jun 20, 2024 as substantially equivalent to K223757 (Disior, Ltd., 2023) after a 106-day review. Its family tree reaches back 7 generations to 1993. 2 later devices descend from it.
- Decided
- Jun 20, 2024
- Review
- 106 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). 2 later devices descend from it, 2 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 backK183105 Mimics MedicalMaterialise NV · 2019
- 2 generations backK203290 BonelogicDisior, Ltd. · 2021
- 1 generation backK223757 BonelogicDisior, Ltd. · 2023
- This deviceK240642 SMART Bun-Yo-Matic CTDisior, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK261641 Lower Limb AI (LLAI)AI Planning Logic, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250023 Smart PCFDDisior, Ltd. · 2025
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 | 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 | K183105 | Mimics Medical | Materialise NV | 2019 | — |
| −2 | K203290 | Bonelogic | Disior, Ltd. | 2021 | — |
| −1 | K223757 | Bonelogic | Disior, Ltd. | 2023 | — |
| 0 (this device) | K240642 | SMART Bun-Yo-Matic CT | Disior, Ltd. | 2024 | — |
| +1 | K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | 2026 | — |
| +1 | K250023 | Smart PCFD | Disior, Ltd. | 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 |
| 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 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 23.5 · 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 |
|---|---|---|---|
| * | K223757 | BonelogicSummary page 6…essment study, were all independent data sets. Each CT image study was allowed to be allocated to only data set. Predicate: Bonelogic (K223757) Substantial The Indications for Use of the subject device and the predicate device are Equivalence: similar. Differences d… | 2023 |
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 31 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K261641 (AI Planning Logic, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K223757.
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. 2024, 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?
SMART Bun-Yo-Matic CT software is to be used by orthopaedic healthcare professionals for diagnosis and surgical planning in a hospital or clinic environment. The medical imaging type intended to be used as the input of the software is Computed Tomography (CT). SMART Bun-Yo-Matic CT software provides: * Visualization report of the three-dimensional mathematical models of the anatomical structures of foot and ankle and three-dimensional models of…
Read the full statement (158 words)
SMART Bun-Yo-Matic CT software is to be used by orthopaedic healthcare professionals for
diagnosis and surgical planning in a hospital or clinic environment. The medical imaging type
intended to be used as the input of the software is Computed Tomography (CT).
SMART Bun-Yo-Matic CT software provides:
* Visualization report of the three-dimensional mathematical models of the anatomical structures of
foot and ankle and three-dimensional models of orthopaedic fixation devices,
* Measurement templates containing radiographic measures of foot and ankle,
* Surgical planning application for visualization of foot and ankle anatomical three-dimensional
structures, radiographic measures, and surgical instrument parameters.
The visualization report containing the measurements can be used for the diagnosis of orthopaedic
healthcare conditions. The surgical planning application containing the visualizations of the three-
dimensional structural models, orthopaedic fixation device models and surgical instrument
parameters combined with the measurements can be used for the planning of treatments and
operations to correct orthopaedic healthcare conditions of foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240642: SMART Bun-Yo-Matic CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240642
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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