Cleared Special

K061189 - DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K061189 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device

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Jun 2006

Decision

34d

Days

Class 2

Risk

K061189 is an FDA 510(k) clearance for the DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on June 1, 2006 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

Submission Details

510(k) Number	K061189 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 28, 2006
Decision Date	June 01, 2006
Days to Decision	34 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

73d faster than avg

Panel avg: 107d · This submission: 34d

Pathway characteristics

Modification to existing cleared device.

Device Classification

Product Code	IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 892.1560

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.