# K092747: Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Oct 9, 2009 after 31 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 K913770 (1991). 63 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner, Philips Medical Systems (Cleveland), Inc. (2004) Summary page 1.
- K070226: Cardioct, Shina Systems, Ltd. (2007) Summary page 1.
- K061370: Cardiq Fusion, GE Healthcare (2006) Summary page 1.
- K060779: Advance Vessel Analysis II, GE Healthcare (2006) Summary page 1.
- K061624: Vitrea, Version 3.9, Vital Images, Inc. (2006) Summary page 1.
- K063762: Syngo Circulation Software Package with Extended Functionality, Siemens AG Medical Solutions (2007) Summary page 1.

## Most influential descendants
- K122429: Vessel Analysis and Autoplaque for Ors Visual (2012), 16 descendants of its own
- K190868: Cleerly Labs (2019), 7 descendants of its own
- K202280: Cleerly Labs v2.0 (2020), 5 descendants of its own
- K212758: Autoplaque (2023), 3 descendants of its own
- K242338: Cleerly LABS (v2.0) (2025), 2 descendants of its own

## Indications for use
The Plaque Analysis option is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques.

Source page: https://510kreport.com/device/K092747
Methodology: https://510kreport.com/methodology