# K060779: Advance Vessel Analysis II

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Apr 5, 2006 after 14 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: 3 generations back to K871859 (1987). 13 ancestors in all.
55 later devices descend from it; 5 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993792: Smart Vessel Analysis (Smart VA) Option, Ge Medical Systems, Inc. (1999) Summary page 1.
- K041267: Cardiq Analysis Iii, General Electric Medical Systems (2004) Summary page 1.
- K031871: Autobone, Ge Medical Systems Europe (2003) Summary page 1.

## Most influential descendants
- K061370: Cardiq Fusion (2006), 51 descendants of its own
- K103465: Synapse 3D Cardiac Tools (2011), 20 descendants of its own
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own
- K092747: Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool (2009), 19 descendants of its own
- K122429: Vessel Analysis and Autoplaque for Ors Visual (2012), 16 descendants of its own

## Indications for use
Advanced Vessel Analysis II is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Advanced Vessel Analysis II (AVA II) is a post processing application option for the Advantage Workstation (AW) platform, CT Scanner or PACS stations, which can be used in the analysis of 2D and 3D CT Angiography images/data derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular and vascular disease assessment. This software is designed to support the physician in assessment of stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization. AVA II automatic visualization tools provide the users with the capabilities to facilitate segmentation of bony structures for accurate identification of the vessels. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a coronary artery, measure area's of abnormalities within a vessel.

Source page: https://510kreport.com/device/K060779
Methodology: https://510kreport.com/methodology