FDA-cleared K212265

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.,LTD

The TEX20, TEX10, TE X, and TE X Lite family provides mobile diagnostic ultrasound across broad adult, obstetric, pediatric, and neonatal applications; K212265 includes AI-based...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2021-11-16