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 · K212265 · 2021-11-16

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 is an AI-enabled medical device from Shenzhen Mindray Bio-Medical Electronics Co.,LTD, listed by FDA (510(k), K212265) with a decision date of 2021-11-16. Review panel: Radiology.

FDA submission numberK212265
Pathway510(k)
CompanyShenzhen Mindray Bio-Medical Electronics Co.,LTD
Review panel (specialty)Radiology
FDA decision date2021-11-16
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)119
Applicant countryCN

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.