Cleared Traditional

ViewMate? Multi Ultrasound System (VMM-ICE-01); ViewMate? Multi Ultrasound System (VMM-ICE-02)

K251250 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology
Sep 2025
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K251250 is an FDA 510(k) clearance for the ViewMate? Multi Ultrasound System (VMM-ICE-01); ViewMate? Multi Ultrasound System (VMM-ICE-02), 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 September 5, 2025, 135 days after receiving the submission on April 23, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K251250 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2025
Decision Date September 05, 2025
Days to Decision 135 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

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