Cleared Traditional

K162845 - DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System (FDA 510(k) Clearance)

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

K162845 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Dec 2016

Decision

65d

Days

Class 2

Risk

K162845 is an FDA 510(k) clearance for the DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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. (Shenzhen, CN). The FDA issued a Cleared decision on December 15, 2016 after a review of 65 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	K162845 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 11, 2016
Decision Date	December 15, 2016
Days to Decision	65 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

42d faster than avg

Panel avg: 107d · This submission: 65d

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.