Color Doppler Ultrasound System mEye1 and mEye2
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182165 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
- Models / Variants
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 Color Doppler Ultrasound System mEye1 and mEye2 is a portable diagnostic imaging device designed for real-time visualization of blood flow and tissue structures within the body. It combines traditional B-mode ultrasound imaging with color Doppler technology to assess vascular flow, organ perfusion, and anatomical details, aiding in the evaluation of cardiovascular, obstetric, and musculoskeletal conditions.
This system is supplied as a reusable medical device, intended for use in clinical, research, or home healthcare settings. It operates under FDA 510K clearance and MDR compliance, with models mEye1 and mEye2 distinguished by their respective specifications. Sterility is not applicable as it is a non-invasive diagnostic tool, and its use requires adherence to standard ultrasound safety protocols, including MRI safety considerations as outlined in its technical documentation.
Frequently asked questions
What clinical settings or conditions is this Color Doppler Ultrasound System primarily used to evaluate?
The mEye1 and mEye2 systems are designed for real-time visualization of blood flow and tissue structures, making them useful for assessing cardiovascular conditions (like blood vessel health), obstetric evaluations (such as fetal monitoring), and musculoskeletal issues (e.g., soft tissue or joint abnormalities). The color Doppler feature specifically helps evaluate vascular flow and organ perfusion, while B-mode imaging provides anatomical details.
Is this device single-use or reusable, and what cleaning or maintenance guidelines should be followed?
The mEye1 and mEye2 are reusable medical devices, so they require proper cleaning and maintenance between uses. Since they are non-invasive diagnostic tools, sterility is not applicable, but standard ultrasound safety protocols—including disinfection of probes and surfaces—must be followed to prevent cross-contamination. Always refer to the manufacturer’s instructions for specific cleaning procedures and MRI safety considerations.
How do the mEye1 and mEye2 models differ from each other, and which one should I choose?
The mEye1 and mEye2 models are distinguished by their respective specifications, though the exact differences are not detailed in the provided data. To determine which model best fits your needs, compare their technical features (e.g., resolution, probe types, or portability) as outlined in the manufacturer’s documentation. Consulting with a radiology specialist or reviewing clinical performance data may also help guide your decision.
What regulatory pathways does this device follow, and how does that affect its use?
The mEye1 and mEye2 systems are cleared under the FDA’s 510(k) pathway (K182165) and comply with the EU’s Medical Device Regulation (MDR). This means they meet U.S. and EU safety and performance standards for diagnostic ultrasound devices. The clearance type is traditional, and the device falls under the Radiology (RA) advisory committee category, indicating it was reviewed for equivalence to existing ultrasound systems. Compliance ensures its use aligns with established medical imaging protocols.
Can this device be used in home healthcare settings, and what considerations should be taken into account?
Yes, the mEye1 and mEye2 are intended for use in home healthcare settings alongside clinical or research environments. However, portability and ease of use are key factors—ensure the device meets your space and technical requirements. Since it’s reusable, proper training for operators (e.g., healthcare professionals or trained caregivers) is critical to maintain accuracy and safety. Always follow the manufacturer’s guidelines for setup, operation, and maintenance in non-clinical environments.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182165 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Well.d Medical Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K182165 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026