Cleared Traditional

K141010 - M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM (FDA 510(k) Clearance)

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

K141010 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device

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May 2014

Decision

26d

Days

Class 2

Risk

K141010 is an FDA 510(k) clearance for the M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGN.... 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. (Shenzhen, CN). The FDA issued a Cleared decision on May 14, 2014 after a review of 26 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	K141010 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 18, 2014
Decision Date	May 14, 2014
Days to Decision	26 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

81d faster than avg

Panel avg: 107d · This submission: 26d

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.