Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163712 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 Clover 50/Clover 60/Clover 70 Diagnostic Ultrasound System is a diagnostic imaging device classified as an Ultrasound Imaging System (FDA Product Code: IYN). It generates real-time visual images of internal body structures using high-frequency sound waves, enabling assessment of organs, tissues, and blood flow across multiple applications, including obstetrics, gynecology, and pediatric care.
This system is intended for use in clinical settings such as hospitals, diagnostic centers, and outpatient facilities. Supplied as a reusable medical device, it requires proper sterilization and maintenance per manufacturer guidelines. The Clover series operates within MRI-safe parameters as defined by the FDA’s 510(k) clearance (K163712), with no restrictions on MRI compatibility. Each model variant (50, 60, 70) denotes incremental performance specifications, though exact technical distinctions are not specified in regulatory filings.
Frequently asked questions
What clinical settings is the Clover series of ultrasound systems designed for and how does its reusable nature impact usage?
The Clover 50/Clover 60/Clover 70 Diagnostic Ultrasound Systems are intended for clinical settings like hospitals, diagnostic centers, and outpatient facilities. As a reusable device, it requires proper sterilization and maintenance following the manufacturer’s guidelines to ensure safety and performance across multiple patients. This design makes it suitable for high-volume environments where frequent use is expected, but it also necessitates adherence to infection control protocols.
How do the model variants (Clover 50, Clover 60, Clover 70) differ in terms of performance, and what should buyers consider when selecting one?
The Clover series includes three model variants (50, 60, 70) that represent incremental performance specifications, though the exact technical distinctions between them are not detailed in regulatory filings. Buyers should consider their specific clinical needs—such as image resolution, speed, or advanced imaging capabilities—when selecting a model. The choice may depend on factors like patient volume, application focus (e.g., obstetrics, pediatrics), and budget, as the differences likely align with these operational requirements.
Can this ultrasound system be used in areas where MRI machines are present, and what safety considerations apply?
Yes, the Clover series is designed to operate within MRI-safe parameters as defined by the FDA’s 510(k) clearance (K163712), meaning it poses no restrictions on MRI compatibility. This allows the system to be used in hybrid or multi-modality environments without interfering with MRI operations. However, users should still follow the manufacturer’s guidelines to ensure safe coexistence with MRI equipment and avoid any potential electromagnetic interference.
What types of imaging applications is this ultrasound system primarily suited for, and how might that influence its adoption?
The Clover series is designed for real-time imaging of internal body structures, making it versatile for applications like obstetrics, gynecology, and pediatric care. Its broad applicability across these fields could influence adoption in facilities specializing in maternal health, women’s health, or pediatric diagnostics. Clinicians in these areas may find its capabilities particularly useful for assessing organs, tissues, and blood flow without the need for specialized models.
How does the regulatory pathway for this device impact its availability or use in clinical practice?
The Clover series received FDA 510(k) clearance through a traditional review process, with a decision code indicating it is substantially equivalent to a predicate device. This pathway ensures the device meets regulatory standards for safety and effectiveness, which can provide confidence to buyers and clinicians about its reliability. Availability is likely widespread in the U.S. market, though adoption may vary based on institutional procurement policies and clinical needs.
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: Clover 50/Clover60/Clover70 Diagnostic Ultrasound System, Clover 50/Clover60/Clover70 Diagnostic ... (K163712) - FDA 510(k), Clover 50/Clover60/Clover70 Diagnostic Ultrasound System, Wisonic, Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163712 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Wisonic Medical Technology Co., Ltd.
- FDA Applicant
- Shenzhen Wisonic Medical Technology Co. , Ltd.
Sources (1)
- FDA 510(k) K163712 24 fields · synced Oct 6, 2026