# K231631: BriefCase-Quantification

- Pathway: 510(k) (Traditional)
- Applicant: Aidoc Medical, Ltd.
- Decided: Nov 28, 2023 after 176 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: 13 generations back to K954678 (1996). 104 ancestors in all.
No later device cites it as a predicate yet.
0 of 105 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.
- K230223: iCAC Device, Bunkerhill, Inc. (2023) Summary page 4.

## Indications for use
BriefCase-Quantification is a software intended for use in the analysis of non-cardiac-gated non-contrast CT (NCCT) images that include the heart in adult patients aged 30 and older. The device is intended to assist physicians by providing the user with a four-category Coronary Artery Calcification (CAC) of plaques, which present a risk for coronary artery disease, together with preview axial images of the detected calcium meant for informational purposes only. The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. Clinicians are responsible for viewing full images per the standard of care.

Source page: https://510kreport.com/device/K231631
Methodology: https://510kreport.com/methodology