# K261272: ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system

- Pathway: 510(k) (Traditional)
- Applicant: Esonic Technology (Wuhan) Co., Ltd.
- Decided: Jul 23, 2026 after 97 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: 27 generations back to K935595 (1995). 435 ancestors in all.
No later device cites it as a predicate yet.
7 of 436 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191007: Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems, Supersonic Imagine (2019) Summary page 6.

## Indications for use
The ultrasound system is indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans- vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac. In addition, the ultrasound diagnostic system and associated transducers are intended for: - Measurements of abdominal anatomical structures, - Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen, - Measurements of brightness ratio between liver and kidney, - Visualization of abdominal vascularization, microvascularization and perfusion, The shear wave speed, beam attenuation, viscosity and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion maybe used as an aid to clinical management of adult and pediatric patients with liver disease. This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device. This system should only be used by trained sonographers who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area. This device is intended to be used in a hospital or medical clinic. Modes of operation include: B-Mode, M-mode, Color Doppler imaging, Pulsed Wave Doppler, Continuous Wave, Harmonic Imaging, Power Doppler imaging, Directional Power Doppler imaging, Contrast Enhanced Ultrasound Imaging, Elasticity Imaging and combined modes: B+ Color Flow, B+ Shear Wave Elastography, B+ Pulsed Wave, B+ Pulsed Wave + Color Flow, B+ M mode, B+ Continuous Wave.

Source page: https://510kreport.com/device/K261272
Methodology: https://510kreport.com/methodology