# K091262: MR Cardiac Function Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Ziosoft, Inc.
- Decided: Jun 29, 2009 after 61 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: 2 generations back to K924605 (1993). 2 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994282: Mri- Flow Analytical Software Package, Medis Medical Imaging Systems BV (2000) Summary page 1.

## Most influential descendants
- K103465: Synapse 3D Cardiac Tools (2011), 20 descendants of its own
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own
- K171222: Vitrea Software Toshiba Package; VSTP-001A (2017), 12 descendants of its own
- K173088: Vitrea Software Toshiba Package VSTP-001A (2018), 11 descendants of its own
- K183013: Vitrea Software Package, VSTP-001A (2018), 9 descendants of its own

## Indications for use
MR Cardiac Function Analysis The MR Cardiac Function Analysis software option for use with Ziostation is intended for non-invasive post-processing of DICOM compliant cardiac MR images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation.

Source page: https://510kreport.com/device/K091262
Methodology: https://510kreport.com/methodology