# K162376: CAAS MR 4D Flow

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Dec 8, 2016 after 106 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: 5 generations back to K010938 (2001). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133937: Heartscan Software, Morpheus Imaging, Inc. (2014) Summary page 4.

## Most influential descendants
- K181825: CAAS MR Solutions (2018), 1 descendant of its own
- K232007: CAAS MR Solutions (2024), 0 descendants of its own
- K191544: Synapse 3D Blood Flow Analysis (2019), 0 descendants of its own

## Indications for use
CAAS MR 4D Flow enables the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images by providing the following functionality: » Segmentation of cardiovascular structures; * Visualization of blood flow velocity and directions; * Calculation of quantitative cardiovascular results. When the results provided by CAAS MR 4D Flow are used in a clinical setting to support diagnoses, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

Source page: https://510kreport.com/device/K162376
Methodology: https://510kreport.com/methodology