# K151126: Foresight Intracardiac Echocardiography (ICE) System

- Pathway: 510(k) (Traditional)
- Applicant: Colibri Technologies, Inc.
- Decided: Dec 18, 2015 after 234 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: 2 generations back to K921750 (1992). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980851: Galaxy Intravascular Ultrasound System, Model I5028, Boston Scientific Corp (1998) Summary page 4.

## Most influential descendants
- K162789: Foresight Intracardiac Echocardiology (ICE) System (2017), 0 descendants of its own

## Indications for use
The Foresight ICE System is indicated for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels of patients. The Foresight ICE System is intended to be used by physicians trained in cardiac catheterization in combination with fluoroscopic imaging and cardiac monitoring equipment with resuscitation equipment readily available.

Source page: https://510kreport.com/device/K151126
Methodology: https://510kreport.com/methodology