Cleared Traditional

K081320 - DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM (FDA 510(k) Clearance)

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

K081320 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device

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May 2008

Decision

15d

Days

Class 2

Risk

K081320 is an FDA 510(k) clearance for the DC-3, DC-3T 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-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on May 27, 2008 after a review of 15 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-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number	K081320 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 12, 2008
Decision Date	May 27, 2008
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF
Third-party Review	Yes - reviewed by an FDA-accredited third party

Regulatory Context

Review time vs. panel average

92d faster than avg

Panel avg: 107d · This submission: 15d

Pathway characteristics

Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.