510(k) · Cleared
ClearedSmart PCFD
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 Sep 29, 2025 as substantially equivalent to K240642 (Disior, Ltd., 2024) and 1 other predicate after a 269-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Sep 29, 2025
- Review
- 269 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
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 backK183105 Mimics MedicalMaterialise NV · 2019
- 3 generations backK203290 BonelogicDisior, Ltd. · 2021
- 2 generations backK223757 BonelogicDisior, Ltd. · 2023
- 1 generation backK240642 SMART Bun-Yo-Matic CTDisior, Ltd. · 2024
- This deviceK250023 Smart PCFDDisior, Ltd. · 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 | K183105 | Mimics Medical | Materialise NV | 2019 | — |
| −3 | K203290 | Bonelogic | Disior, Ltd. | 2021 | — |
| −2 | K223757 | Bonelogic | Disior, Ltd. | 2023 | — |
| −1 | K240642 | SMART Bun-Yo-Matic CT | Disior, Ltd. | 2024 | — |
| 0 (this device) | K250023 | Smart PCFD | Disior, Ltd. | 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 23.5 · 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? (2)
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 |
|---|---|---|---|
| * | K240642 | SMART Bun-Yo-Matic CTSummary page 6…ws for presurgical planning. The device includes the same machine learning derived outputs as the primary predicate SMART Bun-Yo-Matic CT (K240642) device and no new validations were conducted. Details on the previously performed validation are summarized belo… | 2024 |
| * | K223757 | BonelogicSummary page 7…onelogic CT 510(k) Subject Device K240642 K223757 Indications SMART PCFD software SMART Bun-Yo-Matic CT Bonelogic software is to… | 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 3.9 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K240642.
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?
SMART PCFD software includes AI-powered algorithms and is intended to be used to support orthopedic healthcare professionals in the diagnosis and surgical planning of Progressive Collapsing Foot Deformity (PCFD) in a hospital or clinic environment. The medical image modality intended to be used in the software is weight-bearing CT (WBCT). SMART PCFD software provides for the user: * Visualization report of the three-dimensional (3D) mathematical models…
Read the full statement (192 words)
SMART PCFD software includes AI-powered algorithms and is intended to be used to support orthopedic healthcare professionals in the diagnosis and surgical planning of Progressive Collapsing Foot Deformity (PCFD) in a hospital or clinic environment. The medical image modality intended to be used in the software is weight-bearing CT (WBCT).
SMART PCFD software provides for the user:
* Visualization report of the three-dimensional (3D) mathematical models and measurements of the anatomical structures of foot and ankle and three-dimensional models of orthopedic fixation devices,
* Measurement templates containing radiographic measures of foot and ankle, and
* Surgical planning application for visualization of foot and ankle anatomical three-dimensional structures, radiographic measures, and surgical instrument parameters supporting the following common flatfoot procedures: Medial Displacement Calcaneal Osteotomy (MDCO), Lateral Column Lengthening (LCL), and Cotton Osteotomy (CO).
The visualization report containing the measurements is intended to be used to support orthopedic healthcare professionals in the diagnosis of PCFD. The surgical planning application contains the visualizations of the three-dimensional structural models, orthopedic fixation device models and surgical instrument parameters combined with the measurements is intended to be used to support orthopedic healthcare professionals in surgical planning of PCFD.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250023: Smart PCFD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250023
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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