# K213275: EchoGo Core (2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Ultromics Limited
- Decided: Dec 20, 2021 after 81 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: 16 generations back to K935595 (1995). 113 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191171: EchoGo Core, Ultromics, Ltd. (2019) Summary page 5.

## Most influential descendants
- 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/K213275
Methodology: https://510kreport.com/methodology