# K260324: Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Informatics, Inc.
- Decided: May 22, 2026 after 112 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K954678 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122578: Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) Planning, Vital Images, Inc. (2013) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K260324
Methodology: https://510kreport.com/methodology