# K230223: iCAC Device

- Pathway: 510(k) (Traditional)
- Applicant: Bunkerhill, Inc.
- Decided: Apr 25, 2023 after 89 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.
6 later devices descend from it; 5 cite it directly.
0 of 110 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.

## Most influential descendants
- 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
- K242188: ClearRead CT CAC (2024), 0 descendants of its own

## Indications for use
iCAC is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above during routine care. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during routine care and outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only) and both exact and four-category quantitative estimates of the patient’s coronary artery calcium burden in Agatston units. The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device-generated calcium score or score group can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium segmentation in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original chest CT scan; both are still available to be viewed and used at the discretion of the physician. The device is intended to provide information to the physician to provide assistance during review of the patient’s case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient’s results.

Source page: https://510kreport.com/device/K230223
Methodology: https://510kreport.com/methodology