SonoSite iViz Ultrasound System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162288 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 iViz Ultrasound System is a portable ultrasound device designed for diagnostic imaging. It offers excellent imaging performance in a compact, ergonomic form that can be used at the bedside, in emergency departments, or in field settings.
The device is supplied as a portable ultrasound system and is intended for diagnostic use. It received FDA 510(k) clearance with the product code IYN and is manufactured by FUJIFILM Sonosite, Inc. The system is designed for mobility and ease of use in various clinical environments.
Frequently asked questions
What is the SonoSite iViz Ultrasound System used for?
The SonoSite iViz Ultrasound System is intended for diagnostic imaging in clinical settings such as bedside, emergency departments, and field environments, providing portable ultrasound capability for patient assessment.
How is the SonoSite iViz Ultrasound System supplied and what makes it suitable for mobile use?
The device is supplied as a complete portable ultrasound system with an ergonomic, compact design that enables easy transport and operation in diverse clinical environments, supporting mobility and ease of use.
What regulatory pathway was used for the SonoSite iViz Ultrasound System and what was the outcome?
The SonoSite iViz Ultrasound System received FDA 510(k) clearance under submission K162288, with a decision of substantially equivalent (SESE) based on the abbreviated review process and product code IYN in the Radiology advisory committee category.
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 ULTRASOUND, WHEN AND WHERE YOU NEED IT. - Sonosite, SonoSite iViz | Portable Ultrasound Machines | UDS, FUJIFILM SONOSITE IVIZ USER MANUAL Pdf Download, PDF ULTRASOUND, WHEN AND WHERE YOU NEED IT. - Sonosite
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162288 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
Sources (1)
- FDA 510(k) K162288 24 fields · synced Sep 21, 2026