# K251601: Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Dec 3, 2025 after 190 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: 28 generations back to K935595 (1995). 250 ancestors in all.
No later device cites it as a predicate yet.
0 of 251 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200643: Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2020) Summary page 5.

## Indications for use
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Pediatric, small organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, musculo-skeletal (conventional), musculo- skeletal (superficial), thoracic/pleural, Cardiac Adult, Cardiac Pediatric and Peripheral vessel exams. It is intended to provide 50Hz shear wave speed measurements (ViTE: Visual Transient Elastography) and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (LiSA: Liver Ultra-Sound Attenuation) in internal structures of the body. It is also intended to measure spleen stiffness using ViTE at 100 Hz shear wave frequency. The liver stiffness measurement by ViTE may aid the physician in determining the likelihood of cirrhosis and may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of liver fibrosis. The coefficient of attenuation measurement by LiSA may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis. ViTE and LiSA is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of patients with liver disease, as part of an overall assessment of liver. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. Modes of operation include: B, M, PW Doppler, CWD, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Biopsy guidance, Color M, Contrast imaging (Contrast agent for Liver), ViTE, LiSA and Combined mode: B+M, PW+M, Color+B, Power+B, PW+Color+B, Power+PW+B, iScape View, TDI.

Source page: https://510kreport.com/device/K251601
Methodology: https://510kreport.com/methodology