Cleared Traditional

TE Air Diagnostic Ultrasound System

K231685 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology
Oct 2023
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K231685 is an FDA 510(k) clearance for the TE Air Diagnostic Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 26, 2023, 139 days after receiving the submission on June 9, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K231685 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2023
Decision Date October 26, 2023
Days to Decision 139 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

Similar Devices — IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1150
Sonosite iLOOK Ultrasound System
K260595 · FUJIFILM Sonosite, Inc. · Mar 2026
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System
K253049 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2026
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
K253597 · Canon Medical Systems Corporation · Jan 2026
LOGIQ Totus
K253370 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 2026
LOGIQ Fortis
K253366 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 2026
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
K252018 · Samsung Medison Co., Ltd. · Jan 2026

More from Shenzhen Mindray...

View all
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System
K253049 · IYN · Feb 2026
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem
K251601 · IYN · Dec 2025
Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System
K251853 · IYN · Nov 2025
ViewMateTM Ultrasound System
K251820 · IYN · Sep 2025
ViewMate? Multi Ultrasound System (VMM-ICE-01); ViewMate? Multi Ultrasound System (VMM-ICE-02)
K251250 · IYN · Sep 2025