# K212376: Caas Qardia

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: May 16, 2022 after 290 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: 19 generations back to K935595 (1995). 146 ancestors in all.
No later device cites it as a predicate yet.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201632: Tomtec-Arena, Tomtec Imaging Systems GmbH (2020) Summary page 4.

## Indications for use
Standalone software for medical image analysis intended for advanced visualization and quantitative analysis in adult populations to support physicians with diagnostics by means of enabling segmentation, quantification, review, and reporting of cardiac structures based on multi-dimensional echocardiographic images. Caas Qardia facilitates the following use: » Segmentation of cardiovascular structures » Calculation of quantitative indices describing cardiovascular function and structure When the results provided by Caas Qardia are used in a clinical setting to support clinical decision making, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

Source page: https://510kreport.com/device/K212376
Methodology: https://510kreport.com/methodology