# K172983: HealthCCS

- Pathway: 510(k) (Traditional)
- Applicant: Zebra Medical Vision, Ltd.
- Decided: Jun 13, 2018 after 259 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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). 10 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072737: CSCS-001A Calcium Scoring Package, Toshiba America Medical Systems, In.C (2007) Summary page 4.

## Most influential descendants
- K210085: HealthCCSng (2021), 9 descendants of its own
- K230223: iCAC Device (2023), 6 descendants of its own
- K243229: Bunkerhill AVC (2025), 3 descendants of its own
- K192763: syngo.CT CaScoring (2019), 3 descendants of its own
- K201034: Syngo.CT CaScoring (2020), 2 descendants of its own

## Indications for use
The HealthCCS Device is intended for use as a non-invasive post-processing software that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. The software can be used to generate reports of the total risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment. The HealthCCS Device analyses pre-existing heart or chest ECG-Gated/Triggered CT scans. The Device is indicated for use only on patients whose age at the time, when the CT scan was taken, was above 20 years old. This device generates a 4-category Agatston-equivalent risk score, and the patient management, especially for the patient with the score from 0-10, will depend on the physician’s own judgment. It may require further testing to evaluate the appropriate clinical management.

Source page: https://510kreport.com/device/K172983
Methodology: https://510kreport.com/methodology