TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co.,LTDThe TEX20 and TEX10 series Diagnostic Ultrasound Systems by Shenzhen Mindray are versatile, software-controlled ultrasound machines designed for imaging adults, pregnant women, pediatric patients, and neonates. They support multiple imaging modes such as B-mode, Doppler (including Color, Power, Pulsed Wave), 3D imaging, elastography, and contrast imaging, helping clinicians visualize and measure anatomical structures and blood flow across a wide range of body areas including ophthalmic, fetal, abdominal, cardiac, and musculoskeletal exams. These systems enhance diagnostic confidence and efficiency for healthcare providers through advanced imaging features and AI-assisted tools such as Smart Nerve, which assists in visualizing nerve plexuses for guidance.
Intended Use
The TEX20 and TEX10 Diagnostic Ultrasound Systems are applicable for adults, pregnant women, pediatric patients and neonates. Intended for use in ophthalmic, fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, thoracic/pleural, adult and pediatric cardiac, trans-esophageal (cardiac), peripheral vessel, and urology exams.
Technology
Mobile, software-controlled ultrasound systems that acquire and display images in various modes including B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined modes, Tissue Harmonic Imaging, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging, and AI-based features such as Smart Nerve for nerve visualization that support clinical diagnosis.
Performance
The systems underwent comprehensive non-clinical testing including acoustic output, biocompatibility, cleaning and disinfection effectiveness, electrical and mechanical safety, usability, and software validation. Compliance with standards such as IEC 60601 series, ISO 14971 for risk management, ISO 10993 for biocompatibility, and IEC 62304 for software life cycle were demonstrated. Clinical studies were deemed not applicable as the device is substantially equivalent to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/20/2021
3 months - 2
FDA Approval
11/16/2021
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