Cleared Special

K113632 - DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 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.

K113632 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Radiology device
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Jan 2012
Decision
51d
Days
Class 2
Risk

K113632 is an FDA 510(k) clearance for the DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIA.... Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on January 25, 2012 after a review of 51 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-Meidcal Electronics Co., Ltd. devices

Submission Details

510(k) Number K113632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2011
Decision Date January 25, 2012
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
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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