# K132524: CT Transcatheter Aortic Valve Implantation (Tavi) Planning Application

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jun 13, 2014 after 305 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K890348 (1989). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111245: Heartnavigator Release 1, Philips Medical Systems Nederland B.V. (2011) Summary page 5.
- K122578: Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) Planning, Vital Images, Inc. (2013) Summary page 2.

## Recalls of this device
- Nov 9, 2014 · Class II · Z-0473-2015: Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (THV) to be implanted 

## Indications for use
The CT TAVI Planning application is intended to be used for patients with aortic valvular disease, severe symptomatic aortic stenosis or tricuspid aortic valve. The intended part of the body for this application is the human heart specifically the ascending aorta, aortic root, coronary ostia and left ventricle in order to assess the aortic valve in pre-operational planning of transcatheter aortic valve replacement procedures. CT TAVI Planning is a non-invasive post-processing application providing 3D model-based segmentation of the aortic valve and aortic arch. The CT TAVI Planning application provides assessment and measurements of relevant heart structures for TAVI-device sizing, and allows the user to select a starting angle for C-arm position from the possible optimal positions from the CT TAVI and select a C-arm angle the user feels is appropriate to use in the catheterization laboratory by the Interventional team performing the procedure (to be used during the procedure itself). The physician retains the ultimate responsibility for making the determination of patient eligibility or which device is implanted based on their standard practices and additional imaging modalities such as echocardiography.

Source page: https://510kreport.com/device/K132524
Methodology: https://510kreport.com/methodology