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DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM - Digital Color Doppler Ultrasound Imagaing System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103144

by Shantou Institute of Ultrasonic Instruments (Siui

Identifiers

510(k) Number
K103144 FDA 510(k)
FDA Product Code
IYN FDA 510(k)
Models / Variants
Digital Color Doppler Ultrasound Imagaing System FDA 510(k)
Convex / Linear Phased Array Transducer FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a digital color Doppler ultrasound imaging system that includes convex, linear, and phased array transducers. It processes ultrasonic pulse-echo signals to produce 2D (B-mode), M-mode, pulsed-wave Doppler (PWD), color flow mapping (CFM), and 3D imaging. The system supports cine review, image zoom, measurements, calculations, and image storage or printing.

It is used in clinical settings for diagnostic ultrasound imaging. The device is supplied as a system with transducers and is authorized under FDA 510(k) clearance (K103144). No information regarding sterility, single-use or reusable status, MRI safety, specific sizes, or storage conditions is provided in the data.

Frequently asked questions

What is the Digital Color Doppler Ultrasound Imaging System used for?

The system is used in clinical settings for diagnostic ultrasound imaging, producing 2D (B-mode), M-mode, pulsed-wave Doppler, color flow mapping, and 3D images to support anatomical and functional assessment.

What transducers are included with the Digital Color Doppler Ultrasound Imaging System?

The system includes convex, linear, and phased array transducers, enabling versatile imaging across different clinical applications such as abdominal, vascular, and cardiac examinations.

How is the Digital Color Doppler Ultrasound Imaging System supplied and authorized?

The device is supplied as a complete system with transducers and received FDA 510(k) clearance under K103144 on January 12, 2011, based on a traditional submission found substantially equivalent to a predicate device.

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. Sources consulted: Digital Color Doppler Ultrasound Imagaing System; Convex / Linear ..., Digital Color Doppler Ultrasound Imaging System, Convex / Linear ..., 510 (k) K103144 — DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

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Manufacturer

Manufacturer
Shantou Institute of Ultrasonic Instruments (Siui

Sources (1)

  • FDA 510(k) K103144 24 fields · synced Oct 6, 2026