Q: What types of medical conditions can this Diagnostic Ultrasound System help diagnose or monitor, and how does it do that?

The Diagnostic Ultrasound System DC-70 Series generates real-time visual images of internal body structures, aiding in the diagnosis and monitoring of various medical conditions. It falls under the nomenclature code Z11040104, specifically designed for ultrasound imaging. By producing these images, clinicians can assess organs, tissues, and other internal structures to identify abnormalities, track disease progression, or guide treatments, though the exact conditions it supports depend on the clinical expertise and specific models used.

Question 1

What types of medical conditions can this Diagnostic Ultrasound System help diagnose or monitor, and how does it do that?

Accepted Answer

The Diagnostic Ultrasound System DC-70 Series is a Class IIa medical imaging device designed for diagnostic ultrasound examinations. According to nomenclature code Z11040104, it falls under the category of ultrasound systems used to generate real-time visual images of internal body structures, aiding in the diagnosis and monitoring of various medical conditions.

This system is non-sterile, non-reusable, and non-implantable, intended for single-use applications in clinical settings. Models include DC-70, DC-70S, DC-70T, DC-70 Exp, DC-75, DC-78, DC-70 Pro, DC-75 Exp, DC-78 Exp, DC-70W, DC-70 CV, DC-70 Nova, DC-70 Plus, and DC-68. Authorized under FDA 510K and MDR, it is supplied as an active medical device with a unique UDI (69449040AB050100215M) for traceability.

Question 2

Is this device intended for single-use only, and if so, what does that mean for clinical workflows?

Accepted Answer

Yes, the Diagnostic Ultrasound System DC-70 Series is explicitly designed for single-use applications in clinical settings. This means each unit is meant to be used once and then discarded, ensuring patient safety and hygiene. Clinicians should plan accordingly by having multiple units available or using reusable probes (if applicable) while adhering to the system’s single-use designation for the main device components. The non-reusable nature also eliminates the need for reprocessing or sterilization, simplifying workflows.

Question 3

What models are available in the DC-70 Series, and how might a clinician or facility choose between them?

Accepted Answer

The DC-70 Series includes multiple models: DC-70, DC-70S, DC-70T, DC-70 Exp, DC-75, DC-78, DC-70 Pro, DC-75 Exp, DC-78 Exp, DC-70W, DC-70 CV, DC-70 Nova, DC-70 Plus, and DC-68. While the exact specifications (e.g., imaging capabilities, connectivity, or advanced features) vary by model, the choice typically depends on clinical needs—such as whether the facility requires expanded functionality (e.g.,

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number69449040AB050100215M Basic UDI-DI 06944904090191UDI-DI	Date20 Oct 2023Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK211337	Date1 Jul 2021Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK181637	Date9 Jan 2019Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK163690	Date20 Apr 2017Issued	StatusActive
United States	GUDID listing GUDID	Number06944904090191 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) 510(k)	NumberK150204	Date10 Apr 2015Issued	StatusActive

Diagnostic Ultrasound System

Regulatory status

Certificates

Recalls

Coverage

Specification

Truth per registry

Manufacturer details

Overview

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Diagnostic Ultrasound System (Nuewa A20W)

Chemistry Analyzer

D-Dimer Assay Kit (Immunoturbidimetry Method)

Patient monitor

Digital Radiography System

Anti-Thyrotropin Receptor Antibody (CLIA)

Questions

Properties

Other properties (21)