DC-7 Diagnostic Ultrasound System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103583 FDA 510(k)
- FDA Product Code
- IYN 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)
The DC-7 Diagnostic Ultrasound System is a medical imaging device classified as a diagnostic ultrasound system, designed for visualizing internal body structures using high-frequency sound waves. It incorporates color Doppler capabilities to assess blood flow and tissue perfusion, enabling comprehensive evaluations of organs, vessels, and other anatomical features. This system supports a range of diagnostic applications, including obstetrics, cardiology, and general abdominal imaging. Its modular design allows for flexibility in configuring probes and imaging modes to suit specific clinical needs.
The DC-7 is intended for use in clinical, outpatient, and emergency settings where ultrasound imaging is required. It is supplied as a reusable device, requiring proper cleaning, disinfection, and maintenance between uses to ensure sterility and functionality. The system is not labeled for MRI compatibility, and its operation must comply with local regulatory standards. Authorized for commercial distribution in the United States under FDA 510(k) clearance (K103583), it adheres to the product code IYN under the Radiology Advisory Committee’s review. Storage and handling follow manufacturer guidelines to preserve performance and safety.
Frequently asked questions
Is the DC-7 Diagnostic Ultrasound System intended for single-use or reusable in clinical settings, and what maintenance is required?
The DC-7 Diagnostic Ultrasound System is designed for reusable clinical use. Since it is not sterile out-of-the-box, proper cleaning, disinfection, and maintenance between uses are required to ensure sterility and functionality. The manufacturer provides guidelines for storage and handling to maintain performance and safety, which must be followed strictly to comply with regulatory standards.
What types of imaging capabilities does the DC-7 Diagnostic Ultrasound System offer, and in which clinical settings is it commonly used?
The DC-7 incorporates high-frequency sound waves for visualizing internal structures, along with color Doppler technology to assess blood flow and tissue perfusion. It supports applications in obstetrics, cardiology, and general abdominal imaging, making it suitable for clinical, outpatient, and emergency settings where ultrasound diagnostics are required.
How is the DC-7 Diagnostic Ultrasound System configured, and can its features be adjusted for different diagnostic needs?
The DC-7 features a modular design, allowing clinicians to configure probes and imaging modes to match specific diagnostic requirements. This flexibility ensures it can be adapted for various procedures, from routine organ assessments to specialized vascular evaluations.
What regulatory pathway was followed for the DC-7’s commercial distribution in the U.S., and is it compatible with MRI environments?
The DC-7 was cleared for commercial distribution in the U.S. under FDA 510(k) clearance (K103583), determined to be substantially equivalent to a predicate device. However, it is not labeled for MRI compatibility, meaning it should not be used in MRI environments unless explicitly safe for such settings.
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: PDF DC-7 - ultrasoundportables.com, MINDRAY DC-7 QUICK REFERENCE MANUAL Pdf Download, Mindray DC-7 | Medical Imaging | New Ultrasound Systems, Mindray - DC-7 Community, Manuals and Specifications | MedWrench
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103583 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Sources (1)
- FDA 510(k) K103583 24 fields · synced Oct 6, 2026