Cleared Traditional

Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System

K243298 · Carbon (Shenzhen) Medical Device Co., Ltd. · Radiology
Apr 2025
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K243298 is an FDA 510(k) clearance for the Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Carbon (Shenzhen) Medical Device Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 3, 2025, 167 days after receiving the submission on October 18, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K243298 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2024
Decision Date April 03, 2025
Days to Decision 167 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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