SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162045 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 SonoSite SII Ultrasound System and SonoSite Edge II Ultrasound System are portable, handheld ultrasound devices designed for real-time imaging of internal body structures. These systems are classified as diagnostic ultrasound machines, enabling clinicians to visualize organs, tissues, and fluids for diagnostic and procedural guidance in various clinical settings.
These devices are intended for use in clinical environments, including emergency, critical care, and procedural settings. Supplied as reusable systems, they require appropriate cleaning, disinfection, and maintenance per manufacturer guidelines. Both systems carry FDA 510(k) clearance, MDD, and MDR authorizations, ensuring compliance with regulatory standards for diagnostic ultrasound equipment. No specific sterility or MRI safety classifications are noted in the provided data.
Frequently asked questions
Are these ultrasound systems designed for single-use or reusable in clinical settings, and what maintenance is required?
The SonoSite SII and Edge II ultrasound systems are reusable devices, not single-use. They require cleaning, disinfection, and maintenance following the manufacturer’s guidelines to ensure proper functionality and infection control. Since they are portable and intended for use in dynamic environments like emergency or procedural settings, adherence to these protocols is essential to maintain performance and compliance with clinical standards.
What types of clinical environments are these ultrasound systems approved for, and how does their portability factor into their use?
These systems are approved for use in clinical environments including emergency, critical care, and procedural settings, where real-time imaging is critical. Their portable, handheld design makes them ideal for bedside assessments, point-of-care diagnostics, and procedural guidance—such as in trauma, obstetrics, or interventional radiology—where mobility and quick setup are advantages over larger, fixed ultrasound machines.
Do these ultrasound systems come with specific models or configurations, and if so, how might that affect my purchasing decision?
The data provided does not specify distinct models or configurations beyond the two systems (SII and Edge II), but both are portable diagnostic ultrasound machines with comparable core functionalities. The choice between them may depend on factors like image resolution needs, battery life, or specific clinical workflows—details that would require consulting the manufacturer’s technical specifications or comparing user reviews for real-world performance differences.
Are there any special storage requirements for these ultrasound systems, particularly given their reusable nature?
While the provided data does not detail specific storage conditions, reusable medical devices like these typically require protection from physical damage, extreme temperatures, and moisture to preserve functionality. The manufacturer’s guidelines likely include recommendations for clean, dry storage when not in use, along with regular servicing to extend the device’s lifespan and ensure compliance with infection control protocols.
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: Portable, Point-of-Care Ultrasound | FUJIFILM Sonosite, Tragbare Point-of-Care-Ultraschallgeräte | FUJIFILM Sonosite, Ultraschallgeräte | Fujifilm [Deutschland], Welcome to Sonosite, Ultraschallgeräte | Fujifilm [Deutschland]
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162045 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
Sources (2)
- FDA 510(k) K162045 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026