# K020140: Voxar's Calcium Scoring Product

- Pathway: 510(k) (Traditional)
- Applicant: Voxar Limited
- Decided: Jan 28, 2002 after 12 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
No predicates in its family tree.
31 later devices descend from it; 2 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K083446: Cardiac Function Analysis, Calcium Scoring (2009), 29 descendants of its own
- 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

## Indications for use
Voxar Calcium Scoring is a PC based software only application intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using CT image data and clinically accepted calcium scoring algorithms. Voxar calcium scoring is intended to be used by radiologists and other clinicians.

Source page: https://510kreport.com/device/K020140
Methodology: https://510kreport.com/methodology