# K162789: Foresight Intracardiac Echocardiology (ICE) System

- Pathway: 510(k) (Traditional)
- Applicant: Conavi Medical, Inc.
- Decided: Mar 28, 2017 after 175 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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 K921750 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151126: Foresight Intracardiac Echocardiography (ICE) System, Colibri Technologies, Inc. (2015) Summary page 4.
- K992631: Acunav Diagnostic Ultrasound Catheter, Acuson Corp. (1999) Summary page 4.

## Indications for use
The Foresight Intracardiac Echocardiography (ICE) System is indicated for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart and great vessels of patients.

Source page: https://510kreport.com/device/K162789
Methodology: https://510kreport.com/methodology