# K202212: TruPlan

- Pathway: 510(k) (Traditional)
- Applicant: Circle Cardiovascular Imaging, Inc.
- Decided: Feb 19, 2021 after 197 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: 7 generations back to K954678 (1996). 19 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153736: 3mensio Workstation, Pie Medical Imaging BV (2016) Summary page 4.

## Most influential descendants
- K222593: TruPlan Computed Tomography (CT) Imaging Software (2023), 2 descendants of its own
- K260300: WatchMate Software (2026), 0 descendants of its own
- K242166: TribusConnect (2025), 0 descendants of its own

## Indications for use
TruPlan enables visualization and measurement of structures of the heart and vessels for pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure. To facilitate the above, TruPlan provides general functionality such as: » Segmentation of cardiovascular structures * Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR » Simulation of TEE views, ICE views, and fluoroscopic rendering » Measurement and annotation tools * Reporting tools

Source page: https://510kreport.com/device/K202212
Methodology: https://510kreport.com/methodology