Fujifilm SonoSite iViz Ultrasound System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152983 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 Fujifilm SonoSite iViz Ultrasound System is a portable diagnostic ultrasound device designed for real-time imaging of internal body structures. It employs high-frequency sound waves to generate visual images of tissues, organs, and blood flow, aiding in the diagnosis and monitoring of various medical conditions.
This system is intended for use in clinical settings such as hospitals, emergency departments, and outpatient care facilities. Supplied as a reusable device, it requires proper maintenance and sterilization protocols where applicable. The system adheres to FDA 510(k) clearance and MDD standards, ensuring compliance with regulatory requirements for diagnostic ultrasound equipment. It is classified under product code IYN and is intended for professional medical use only.
Frequently asked questions
Is the Fujifilm SonoSite iViz Ultrasound System designed for single-use or reusable applications, and what maintenance is required?
The Fujifilm SonoSite iViz Ultrasound System is a reusable device, meaning it is built for repeated use in clinical settings like hospitals and emergency departments. Since it is not single-use, it requires proper maintenance and sterilization protocols to ensure safety and functionality between uses. The manufacturer recommends following established guidelines for cleaning, disinfection, and storage to prevent contamination and maintain performance.
What types of medical environments is the iViz system intended for, and how does its portability factor into its use?
The iViz system is specifically designed for portable diagnostic imaging in dynamic clinical settings such as hospitals, emergency departments, and outpatient care facilities. Its portability allows clinicians to perform real-time ultrasound imaging at the patient’s bedside or in remote areas where traditional imaging equipment may not be practical. This makes it ideal for urgent evaluations, point-of-care diagnostics, and situations where mobility is critical.
What regulatory pathways has the iViz system undergone, and how does that affect its use in clinical practice?
The iViz system has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD) standards, confirming its safety and effectiveness for professional medical use. These regulatory pathways ensure that the device meets established performance criteria for diagnostic ultrasound equipment, allowing clinicians to rely on its imaging accuracy and reliability in clinical decision-making. The clearance also indicates it is intended for professional use only, not for self-administration.
What kind of imaging capabilities does the iViz system provide, and how does it assist in medical diagnostics?
The iViz system uses high-frequency sound waves to generate real-time visual images of internal body structures, including tissues, organs, and blood flow. This capability aids in diagnosing and monitoring various medical conditions by providing immediate visual feedback for clinicians. Its real-time imaging is particularly useful in emergency settings, where quick assessments are essential, or in outpatient care for ongoing patient evaluation.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K152983 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
Sources (2)
- FDA 510(k) K152983 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026