# K241440: HealthCCSng

- Pathway: 510(k) (Special)
- Applicant: Nano-X AI, Ltd.
- Decided: Aug 19, 2024 after 90 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: 12 generations back to K954678 (1996). 103 ancestors in all.
No later device cites it as a predicate yet.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210085: HealthCCSng, Zebra Medical Vision, Ltd. (2021) Summary page 4.

## 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 HealthCCSng device analyzes routine non-gated, non-contrast CT studies that include the entire heart of adult patients of age 30-85. The device generates an exact calcium score and a four coronary artery calcium detection 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. A list of studies that received a successful algorithm analysis result will also be available for further clinician assessment (such as by a cardiologist, general practitioner etc.). 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/K241440
Methodology: https://510kreport.com/methodology