# K181825: CAAS MR Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Dec 4, 2018 after 148 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 K940172 (1994). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162112: Caas MRV, Pie Medical Imaging BV (2016) Summary page 4.
- K090155: Caas MR Flow 1.0, Pie Medical Imaging BV (2009) Summary page 4.
- K162376: CAAS MR 4D Flow, Pie Medical Imaging BV (2016) Summary page 4.
- K140587: MR-CT Vva, Medis Medical Imaging Systems BV (2015) Summary page 4.

## Most influential descendants
- K232007: CAAS MR Solutions (2024), 0 descendants of its own

## Indications for use
CAAS MR Solutions features segmentation of cardiovascular structures and enables the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images as well as measurement and reporting tools by providing the following functionality: • Segmentation of cardiovascular structures and calculation of quantitative results • Support signal intensity analysis for the myocardium • Quantification of MR parametric maps (such as T1, T2, T2* relaxation) • Visualization and quantification of blood flow velocity and directions When the results provided by CAAS MR Solutions 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/K181825
Methodology: https://510kreport.com/methodology