# K260169: AV Cardiac CT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Mar 5, 2026 after 44 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: 9 generations back to K930090 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150665: Philips Spectral CT Applications, Philips Medical Systems Nethrlands BV (2015) Summary page 5.

## Indications for use
The AV Cardiac CT applications are intended to assist the user in viewing, processing, analysis of CT datasets and in preparation of cardiac interventions. The CT Coronary Analysis application is indicated to assist radiologists, cardiologists, and 3D technologists in the analysis of coronary artery anatomy for patients with suspected or diagnosed cardiac disease including coronary artery disease. The CT Functional Analysis application is indicated to assist radiologists, cardiologists, and 3D technologists in the analysis of heart anatomy and function, for patients with suspected or diagnosed cardiac disease.

Source page: https://510kreport.com/device/K260169
Methodology: https://510kreport.com/methodology