# K191171: EchoGo Core

- Pathway: 510(k) (Traditional)
- Applicant: Ultromics, Ltd.
- Decided: Nov 13, 2019 after 196 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 15 generations back to K935595 (1995). 112 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150122: Tomtec-Arena TTA2, Tomtec Imaging Systems GmbH (2015) Summary page 4.

## Most influential descendants
- K213275: EchoGo Core (2.0) (2021), 1 descendant of its own
- K250670: EchoConfidence (USA) (2025), 0 descendants of its own
- K234141: AISAP Cardio V1.0 (2024), 0 descendants of its own

## Indications for use
EchoGo Core is intended to be used for quantification and reporting of results of cardiovascular function to support physician diagnosis. EchoGo Core is indicated for use in adult populations.

Source page: https://510kreport.com/device/K191171
Methodology: https://510kreport.com/methodology