Cleared Traditional

DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System (K173369) - FDA 510(k) Clearance

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

K173369 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Radiology device
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Dec 2017
Decision
47d
Days
Class 2
Risk

K173369 is an FDA 510(k) clearance for the DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic 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 Mindray Bio-Meidcal Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 13, 2017 after a review of 47 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. devices

Submission Details

510(k) Number K173369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2017
Decision Date December 13, 2017
Days to Decision 47 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 107d · This submission: 47d
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 632
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K173369.
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
K163712 · Shenzhen Wisonic Medical Technology Co. , Ltd. · Jan 2018
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K172860 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2018
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