# K250120: GECHO

- Pathway: 510(k) (Traditional)
- Applicant: Narnar, LLC
- Decided: Jul 14, 2025 after 179 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K935595 (1995). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181264: QLAB Advanced Quantification Software, Philips Ultrasound, Inc. (2018) Summary page 5.

## Indications for use
GECHO is a software package intended to visually assess contrast-enhanced echocardiography for left ventricular function and myocardial blood flow by displaying enhanced images of the heart and Time-To-Replenish images. GECHO is intended for use by a cardiologist. GECHO is for use on images of adult patients who underwent contrast-enhanced echocardiography.

Source page: https://510kreport.com/device/K250120
Methodology: https://510kreport.com/methodology