# K213102: ES1 System

- Pathway: 510(k) (Traditional)
- Applicant: E-Scopics
- Decided: Jan 11, 2022 after 109 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K935595 (1995). 162 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203273: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630), Echosens (2021) Summary page 5.

## Most influential descendants
- K232336: ES Series V2 (2023), 2 descendants of its own
- K260748: ES-Series (2026), 0 descendants of its own
- K260589: ES-Series (2026), 0 descendants of its own

## Indications for use
The ES1 Ultrasound Diagnostic System is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound beam attenuation and estimates of speed of sound, in internal structures of the body. This device is intended to be used by trained healthcare professionals, in a healthcare environment. The ES1 Ultrasound Diagnostic System is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the ES1 ultrasound diagnostic system is intended to provide: - Linear distance measurements of anatomical structures, - Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen, - Estimates of ultrasound attenuation coefficient in the liver at 3.5 MHz, - Measurement of brightness ratio between structures and in particular between the liver and the kidney, - Estimates of speed of sound in the liver. The shear wave speed measurements, ultrasound beam attenuation, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.

Source page: https://510kreport.com/device/K213102
Methodology: https://510kreport.com/methodology