# K110447: Echoinsight

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasound Medical Devices, Inc.
- Decided: May 27, 2011 after 100 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: 12 generations back to K935595 (1995). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091286: Syngo US Workplace, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.

## Indications for use
Intended for use by or on the order of a qualified physician for analysis of ultrasound imaging of the human heart. Cardiac (adult and pediatric) applications using B-mode (including harmonic) imaging are supported. The system provides image data analysis applications that supply information on cardiac structure and motion.

Source page: https://510kreport.com/device/K110447
Methodology: https://510kreport.com/methodology