Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);
Shenzhen Mindray Bio-medical Electronics Co., LTD.The Diagnostic Ultrasound System MX6 series by Shenzhen Mindray Bio-medical Electronics Co., LTD is a general-purpose, software-controlled ultrasound imaging device for a wide range of clinical applications including adult, pediatric, and neonatal exams. It supports various ultrasound modes such as B-mode, Doppler, Color Doppler, 3D/4D imaging, elastography, and contrast imaging. This device aids healthcare professionals in capturing, measuring, and analyzing ultrasound images to support medical diagnosis across multiple body regions such as abdomen, obstetrics, gynecology, cardiac, and musculoskeletal systems.
Intended Use
The 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, intended for use in a hospital or medical clinic across multiple anatomical areas and patient populations.
Technology
The system is a mobile, software controlled ultrasonic diagnostic system. It acquires and displays ultrasound images in multiple modes such as B, M, PWD, CWD, Color Doppler, Amplitude Doppler, combined modes, Tissue Harmonic Imaging, 3D and 4D real-time imaging, strain elastography, and contrast imaging with specific contrast agents. It supports anatomical measurements and includes analysis packages for clinical use.
Performance
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and electrical, mechanical, and thermal safety in compliance with relevant medical safety standards (NEMA, IEC, ISO, ANSI). No clinical studies were required as performance was demonstrated via comprehensive non-clinical tests.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/16/2025
4 months - 2
FDA Approval
5/16/2025
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