Cleared Traditional

K182165 - Color Doppler Ultrasound System (FDA 510(k) Clearance)

Also includes:
Model: mEye1 and mEye2

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182165 · Shenzhen Well.D Medical Electronics Co., Ltd. · Radiology device
Dec 2018
Decision
132d
Days
Class 2
Risk

K182165 is an FDA 510(k) clearance for the Color Doppler Ultrasound System. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Shenzhen Well.D Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 20, 2018 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K182165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2018
Decision Date December 20, 2018
Days to Decision 132 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 128d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 168
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K182165.
EVO Q30 Diagnostic Ultrasound System
K254099 · Samsung Medison Co., Ltd. · Mar 2026
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
K253595 · Philips Ultrasound, LLC · Mar 2026
Butterfly Gestational Age Tool
K252148 · Butterfly Network, Inc. · Mar 2026
LOGIQ Vita
K260673 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Mar 2026
Sonio Detect (v3)
K252433 · Sonio · Mar 2026
Sonosite iLOOK Ultrasound System
K260595 · FUJIFILM Sonosite, Inc. · Mar 2026