# K210085: HealthCCSng

- Pathway: 510(k) (Traditional)
- Applicant: Zebra Medical Vision, Ltd.
- Decided: Sep 15, 2021 after 245 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: 11 generations back to K954678 (1996). 102 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172983: HealthCCS, Zebra Medical Vision, Ltd. (2018) Summary page 4.
- K183268: AI-Rad Companion (Cardiovascular), Siemens Medical Solutions USA, Inc. (2019) Summary page 4.

## Most influential descendants
- K230223: iCAC Device (2023), 6 descendants of its own
- K243229: Bunkerhill AVC (2025), 3 descendants of its own
- K260166: Bunkerhill Contrast CAC (2026), 0 descendants of its own
- K260167: Bunkerhill Contrast AVC (2026), 0 descendants of its own
- K250662: Bunkerhill MAC (2025), 0 descendants of its own

## Indications for use
The HealthCCSng device is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The software generates an estimated coronary artery calcium detection category. The HealthCCSng device analyzes existing non-cardiac-gated CT studies that include the heart of adult patients above the age of 30. The device generates a three-category output representing the estimated quantity of calcium detected together with preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies.

Source page: https://510kreport.com/device/K210085
Methodology: https://510kreport.com/methodology