# K140587: MR-CT Vva

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Jan 6, 2015 after 305 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 K940172 (1994). 18 ancestors in all.
19 later devices descend from it; 8 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073194: Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools, Cardiovascular Imaging Solutions, Ltd. (2008) Summary page 4.
- K121762: Cardiac VX, Ge Medical Systems, LLC (2013) Summary page 4.

## Most influential descendants
- 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
- K163253: Arterys Cardio DL (2017), 4 descendants of its own
- K212421: ADAS 3D (2021), 3 descendants of its own

## Indications for use
MR-CT VVA is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, MR-CT VVA allows the quantification of T2* in MR images of the heart and the liver. Finally, MR-CT VVA can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by MR-CT VVA are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.

Source page: https://510kreport.com/device/K140587
Methodology: https://510kreport.com/methodology