Cleared Special

K150080 - DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S (FDA 510(k) Clearance)

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

K150080 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device

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Jun 2015

Decision

148d

Days

Class 2

Risk

K150080 is an FDA 510(k) clearance for the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S. 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 June 12, 2015 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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. Standard predicate reliance. 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	K150080 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 15, 2015
Decision Date	June 12, 2015
Days to Decision	148 days
Submission Type	Special
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

41d slower than avg

Panel avg: 107d · This submission: 148d

Pathway characteristics

Modification to existing cleared device. 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.