510(k) · Cleared
ClearedVitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Informatics, Inc. · QIH Automated Radiological Image Processing Software
Cleared on May 22, 2026 as substantially equivalent to K122578 (Vital Images, Inc., 2013) after a 112-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- May 22, 2026
- Review
- 112 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954678 (1996). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 3 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 2 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 1 generation backK122578 Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) PlanningVital Images, Inc. · 2013
- This deviceK260324 Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −3 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −2 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −1 | K122578 | Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) Planning | Vital Images, Inc. | 2013 | — |
| 0 (this device) | K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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.
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 30 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K122578.
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?
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive post-processing application designed to assist medical professionals with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures. Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning includes general functionality such as: • The software processes CT (computed…
Read the full statement (208 words)
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive post-processing application designed to assist medical professionals with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning includes general functionality such as:
• The software processes CT (computed tomography) image data to provide 3D segmentation of heart structures and vessels relevant to approach planning.
• The user can review the 2D and 3D images to select and plan the delivery path.
• The user can determine C-arm angles for use during the procedure.
• The user can verify and adjust the results of segmentation and cross-section measurements.
• The software provides visualization techniques such as volume rendering, MIP, MPR and curved MPR.
• The user can identify and edit contours and the centerline automatically or manually.
• The user can generate a report with relevant approach planning data and measurements for device sizing.
• The software can provide visualization of calcium.
• The user can generate tortuosity calculations along a centerline.
The TAVR Planning Assist feature offers the ability to automatically initialize visualizations and measurements, that users can edit. The calculation of these outputs utilizes artificial intelligence/machine learning methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260324: Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260324
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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