# K073194: Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Imaging Solutions, Ltd.
- Decided: Feb 14, 2008 after 93 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: 3 generations back to K940172 (1994). 3 ancestors in all.
28 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994283: Mri- Magnetic Resonance Analytical Software System, Medis Medical Imaging Systems BV (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K060941: Caas MRV Version 3.0, Pie Medical Imaging BV (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K140587: MR-CT Vva (2015), 19 descendants of its own
- K113620: Myrian 1.11 (2012), 6 descendants of its own
- K191125: ADAS 3D (2020), 5 descendants of its own
- K162513: Arterys Software v2.0 (2016), 5 descendants of its own
- K210850: ADAS 3D (2021), 4 descendants of its own

## Indications for use
CMRtoolsTM and plug-ins VentricularTools TM & ThalassaemiaToolsTM is a software device used for viewing and analyzing cardiovascular magnetic resonance images. It allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plug-ins have comprehensive quantification facilities with full analysis session recording for providing comprehensive audit trails. It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing cine images and performing region-of-interest analysis. Plug-ins are used for specialist cardiac assessment including VentricularTools for left ventricular assessment and ThalassaemiaTools for T2* image quantification. It is important that CMRtools is only used to view and analyze human cardiac and or liver images acquired with a cardiovascular magnetic resonance scanner. CMRtools must not be used to view or analyze images acquired with any other type of imaging device. The software must not be used to view or analyze images of any part of the body except the heart and or liver or the vascular system. Furthermore, the software must not be used to view or analyze images acquired from animals. Only DICOM images will be used for presentation, display and diagnosis.

Source page: https://510kreport.com/device/K073194
Methodology: https://510kreport.com/methodology