510(k) · Cleared
ClearedLower Limb AI (LLAI)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AI Planning Logic, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Aug 18, 2026 as substantially equivalent to K240642 (Disior, Ltd., 2024) and 1 other predicate after a 92-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Aug 18, 2026
- Review
- 92 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K896095 (1990). 36 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 10 generations between
- 3 generations backK250042 PeekMed webPeek Health, S.A. · 2025
- 2 generations backK251096 PeekMed webPeek Health, S.A. · 2025
- 1 generation backK252856 PeekMed webPeek Health, S.A. · 2025
- This deviceK261641 Lower Limb AI (LLAI)AI Planning Logic, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 13 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 12 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 11 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 10 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 9 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 8 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 7 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 6 generations backK182464 PeekMedPeek Health, S.A. · 2018
- 5 generations backK222767 PeekMed web (v1)Peek Health, S.A. · 2022
- 4 generations backK240926 PeekMed webPeek Health, S.A. · 2024
- 3 generations backK250042 PeekMed webPeek Health, S.A. · 2025
- 2 generations backK251096 PeekMed webPeek Health, S.A. · 2025
- 1 generation backK252856 PeekMed webPeek Health, S.A. · 2025
- This deviceK261641 Lower Limb AI (LLAI)AI Planning Logic, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −13 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −12 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −11 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −10 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −9 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −8 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −7 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −6 | K182464 | PeekMed | Peek Health, S.A. | 2018 | — |
| −5 | K222767 | PeekMed web (v1) | Peek Health, S.A. | 2022 | — |
| −4 | K240926 | PeekMed web | Peek Health, S.A. | 2024 | — |
| −3 | K250042 | PeekMed web | Peek Health, S.A. | 2025 | — |
| −2 | K251096 | PeekMed web | Peek Health, S.A. | 2025 | — |
| −1 | K252856 | PeekMed web | Peek Health, S.A. | 2025 | — |
| 0 (this device) | K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 5…ory Class: Class II Product Code: QIH Review Panel: Radiology Primary Predicate: SMART Bun-Yo-Matic CT (K240642) Reference Predicate: PeekMed Web (K252856) Device Description: Lower Limb AI (LLAI) is a cloud-based Software as a… | 2024 |
| * | K252856 | PeekMed webSummary page 5…QIH Review Panel: Radiology Primary Predicate: SMART Bun-Yo-Matic CT (K240642) Reference Predicate: PeekMed Web (K252856) Device Description: Lower Limb AI (LLAI) is a cloud-based Software as a Medical Device that processes lower-limb CT imaging to… | 2025 |
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 36 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 36 ancestors have a recall of any class.
- 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. 2026, 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?
The Al Planning Logic (AIPL) Lower Limb Al (LLAI) is software intended for use by orthopedic healthcare professionals in the preoperative planning of knee osteotomy procedures. The device processes CT images of the lower limb to provide:
» Automated segmentation and 3D reconstruction of bony anatomy
» Quantitative measurement of lower limb alignment, including mechanical and anatomical axis angles
» Visualization of anatomical structures and surgical planning outcomes in a virtual 3D environment
The software is intended to be used as an adjunctive tool to support clinical judgment and is not intended to provide diagnostic information or to replace the surgeon’s decision-making process.
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/K261641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261641: Lower Limb AI (LLAI).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261641
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026