# K232007: CAAS MR Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Feb 1, 2024 after 210 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: 8 generations back to K940172 (1994). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181825: CAAS MR Solutions, Pie Medical Imaging BV (2018) Summary page 4.
- K163076: Segment CMR, Medviso AB (2017) Summary page 4.

## Indications for use
Standalone software for medical image analysis intended for advanced visualization and quantitative analysis for diagnostics in the field of cardiology or radiology by means of segmentation of cardiovascular structures and enabling 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/K232007
Methodology: https://510kreport.com/methodology