# K260748: ES-Series

- Pathway: 510(k) (Traditional)
- Applicant: E-Scopics
- Decided: Jun 9, 2026 after 95 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: 25 generations back to K935595 (1995). 264 ancestors in all.
No later device cites it as a predicate yet.
0 of 265 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232336: ES Series V2, E-Scopics (2023) Summary page 5.
- K183575: ACUSON S3000, S2000 Diagnostic Ultrasound System, Siemens Healthineers (2019) Summary page 5.
- K223902: FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630), Echosens (2023) Summary page 5.

## Indications for use
The device 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 tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment. The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the device 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 tissue brightness parameters in the liver at selected ultrasound frequencies - Measurement of brightness ratio between structures and in particular between the liver and the kidney, - Estimates of speed of sound in the liver, - Estimates of an ultrasound-derived fat fraction index. The shear wave speed measurements, ultrasound tissue brightness parameters, 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.The Hepatoscope ultrasound-derived fat fraction index (HDFF) may be used as an aid to the clinical management of adult patients with liver steatosis.

Source page: https://510kreport.com/device/K260748
Methodology: https://510kreport.com/methodology