# K200643: Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jul 24, 2020 after 135 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). 249 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 251 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180912: TE7/TE5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2018) Summary page 6.

## Most influential descendants
- 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 (2025), 0 descendants of its own

## Indications for use
Hepatus 7/Hepatus 6/Hepatus S/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus ST/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 and Peripheral vessel exams. It is intended to provide 50 Hz 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. The ViTE and stiffness, and LiSA may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of liver. The ViTE and stiffness may be used as an aid to clinical management of pediatric patients with liver disease. The clinical applications include:Fetal, Abdominal, Pediatric and Peripheral vessel. 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, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Biopsy guidance, Color M, Contrast imaging(Contrast agent for Liver), VIiTE, LiSA and Combined mode:B+M, PW+M, Color+B, Power+B, PW+Color+B, Power+PW+B.

Source page: https://510kreport.com/device/K200643
Methodology: https://510kreport.com/methodology