# K122578: Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) Planning

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Feb 25, 2013 after 186 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 6 generations back to K954678 (1996). 7 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120367: 3MENSIO Workstation, Pie Medical Imaging BV (2012) Summary page 1.

## Most influential descendants
- K151212: Ziostation2 (2015), 2 descendants of its own
- K181892: Ziostation2 (2018), 1 descendant of its own
- K260324: Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning (2026), 0 descendants of its own
- K200315: Ziostation2 (2020), 0 descendants of its own
- K132524: CT Transcatheter Aortic Valve Implantation (Tavi) Planning Application (2014), 0 descendants of its own

## 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 20 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.

Source page: https://510kreport.com/device/K122578
Methodology: https://510kreport.com/methodology