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 · System, Imaging, Pulsed Doppler, Ultrasonic

What it does

Supports the imaging workflow around multi-modality studies — routing, scheduling, or image management — rather than interpreting the images.

Who it's for

Imaging departments and informatics teams managing study flow.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)

Submission #K212265

Product codeIYN

Decision dateNov 16, 2021

PanelRadiology

FDA recordaccessdata

EU (CE)

Statusunknown

Risk class—

Notified body—

EMDN code—

Basic UDI-DI—

AI Act class—

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Company🇨🇳Shenzhen Mindray Bio-Medical Electronics Co.,LTD

Foundedunknown

Cite this page

RadPigeon. "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)." AI Devices registry. https://radpigeon.news/ai/device/tex20-tex20-pro-tex20s-tex20t-tex20-exp-tex20-elite-diagnostic-ultrasound-system

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.