# K083446: Cardiac Function Analysis, Calcium Scoring

- Pathway: 510(k) (Traditional)
- Applicant: Ziosoft, Inc.
- Decided: Mar 31, 2009 after 130 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 K945512 (1995). 14 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023760: CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001B, Toshiba America Medical Systems, In.C (2002) Summary page 1.
- K072737: CSCS-001A Calcium Scoring Package, Toshiba America Medical Systems, In.C (2007) Summary page 1.
- K020140: Voxar's Calcium Scoring Product, Voxar Limited (2002) Summary page 1.

## Most influential descendants
- K111373: CT42 Cardiac Computed Tomography (CT) Software (2011), 25 descendants of its own
- K203256: Imbio RV/LV Software (2021), 17 descendants of its own
- K213998: cvi42 Auto Imaging Software Application (2022), 7 descendants of its own
- K221100: Viz RV/LV (2022), 4 descendants of its own
- K230534: BriefCase-Quantification (2023), 3 descendants of its own

## Indications for use
Cardiac Function Analysis The Cardiac Function Analysis software option for use with Ziostation is intended for non-invasive post-processing of DICOM compliant cardiac CT 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. Calcium Scoring The Calcium Scoring software option for use with Ziostation is a non-invasive post processing software tool that can be used with CT images to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease.

Source page: https://510kreport.com/device/K083446
Methodology: https://510kreport.com/methodology