Cleared Special

K061189 - DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC I...

K061189 is the FDA 510(k) clearance for DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC I... by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Radiology device (product code IYO) cleared through the Special 510(k) pathway after a 34-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

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