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Digital Ultrasonic Diagnostic Imaging System Model DP-6900

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K090912

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Identifiers

510(k) Number
K090912 FDA 510(k)
FDA Product Code
ITX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1570 FDA 510(k)
Regulation Number
892.1570 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Digital Ultrasonic Diagnostic Imaging System Model DP-6900 is a diagnostic ultrasound device designed for real-time imaging of internal body structures. It generates high-resolution images using ultrasound waves to assist in the evaluation of organs, tissues, and blood flow, supporting clinical assessments in radiology and diagnostic medicine.

This system is supplied by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., and is intended for use in clinical settings. It is classified under the product code ITX and has received FDA 510(k) clearance as substantially equivalent, along with MDR authorization. The device is not described as single-use or reusable, nor are MRI safety details provided in the specifications.

Frequently asked questions

What clinical specialties or departments would benefit most from using the Digital Ultrasonic Diagnostic Imaging System, Model DP-6900?

The Model DP-6900 is primarily designed for use in radiology departments and diagnostic medicine settings. Its real-time imaging capabilities assist in evaluating internal body structures, organs, tissues, and blood flow, making it particularly useful for clinicians in radiology, obstetrics/gynecology, cardiology, and general internal medicine who rely on ultrasound for diagnostic assessments.

How is the Digital Ultrasonic Diagnostic Imaging System, Model DP-6900, regulated, and what does that mean for its use in clinical settings?

The Model DP-6900 has received FDA 510(k) clearance under the product code ITX, with a decision of substantially equivalent to a predicate device, and MDR authorization. This means it has undergone regulatory review to ensure safety and effectiveness for its intended use in diagnostic imaging, allowing it to be legally marketed and used in clinical settings in the U.S. and EU, respectively.

Is the Model DP-6900 intended for single-use or repeated use in clinical environments?

The provided data does not specify whether the Model DP-6900 is single-use or reusable. However, as it is a diagnostic imaging system designed for clinical settings, it is likely intended for repeated use with appropriate maintenance and sterilization protocols (if applicable) to ensure consistent performance and patient safety. Always follow manufacturer guidelines for cleaning and disinfection.

Who is the manufacturer responsible for the Digital Ultrasonic Diagnostic Imaging System, Model DP-6900, and where can I contact them for support?

The manufacturer of the Model DP-6900 is Shenzhen Mindray Bio-Medical Electronics Co., Ltd., based at Mindray Bldg., Keji 12th Rd. S., Hi-Tech Industrial Park, Nanshan, Shenzhen, China (518057). For support or inquiries, you may contact TAN CHUANBIN, though direct contact details beyond the name are not provided in the data. The manufacturer’s official channels should be consulted for technical or service-related assistance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Sources (2)

  • FDA 510(k) K090912 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026