Cleared Traditional

K183041 - Full Digital Colour Doppler Ultrasonic ...

K183041 is the FDA 510(k) clearance for Full Digital Colour Doppler Ultrasonic ... by Wuhan Zoncare Bio-medical Electronics Co., Ltd.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K183041 · Wuhan Zoncare Bio-medical Electronics Co., Ltd. · Radiology device
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Jul 2019
Decision
251d
Days
Class 2
Risk

K183041 is an FDA 510(k) clearance for the Full Digital Colour Doppler Ultrasonic Diagnostic 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 Wuhan Zoncare Bio-medical Electronics Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on July 10, 2019 after a review of 251 days - an extended review cycle.

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.

View all Wuhan Zoncare Bio-medical Electronics Co., Ltd. devices

Submission Details

510(k) Number K183041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2018
Decision Date July 10, 2019
Days to Decision 251 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 107d · This submission: 251d
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 Consultant

Shenzhen Hlongmed Biotech Co., Ltd.
Long Yang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

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