Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class II · Cleared Dec 3, 2025
| K-number | K251601 |
| Device name | 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 |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product code | IYN |
| Device class | Class II |
| Decision date | Dec 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
The Hepatus 7/6/5 and Fibrous 7/6/5 Diagnostic Ultrasound System is a general-purpose, mobile ultrasound device intended for imaging adults, pregnant women, pediatric patients, and neonates across multiple anatomical areas including fetal, abdominal, cardiac, musculoskeletal, and small organ examinations. It provides standard B-mode, Doppler, color flow imaging, and specialized measurements including liver stiffness (ViTE) and liver fat content (LiSA) to aid in assessment of liver disease.
The device operates in B, M, PW Doppler, CWD, Color Doppler, Tissue Harmonic Imaging, and combined modes with new features including: expanded indications for small organs (breast, thyroid, testes), neonatal/adult cephalic, musculoskeletal, thoracic/pleural, and cardiac imaging; spleen stiffness measurement at 100 Hz shear wave frequency; new transducers (LFC5-1s, L9-3s, L15-3RCs, P4-2s) and needle-guided brackets with same patient contact materials as reference devices; acoustic power levels below FDA limits matching the predicate.
NEMA UD 2-2004 (acoustic output); ANSI AAMI ES60601-1:2005 and amendments (electrical safety); IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37 (medical electrical equipment standards); ISO 14971 (risk management); ISO 10993-1 (biocompatibility); IEC 62304 (software lifecycle); IEC 62366-1 (usability engineering).
The subject device has the same indications for use as primary predicate Hepatus 7 (K200643) with added indications matching reference device MX7 (K241432) for small organs and cardiac imaging; equivalent imaging modes and features; acoustic power below FDA limits; compliance with same electrical and physical safety standards as the predicate; and substantially equivalent spleen ViTE feature to reference device FibroScan (K223902). All systems transmit ultrasonic energy, process echoes to generate anatomic displays, and allow specialized measurements and calculations.
View the full FDA submission: accessdata.fda.gov