Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ul…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202160 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 PX, SII, iViz, X-Porte, Edge II, and Maxx Ultrasound Systems are portable diagnostic imaging devices designed for real-time visualization of internal body structures using high-frequency sound waves. These systems are classified as ultrasound machines, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes across various clinical settings.
These systems are intended for use in clinical environments, including emergency departments, intensive care units, and procedural rooms, where portability and rapid imaging are critical. Supplied as reusable medical devices, they require adherence to manufacturer cleaning and sterilization protocols. Each model adheres to FDA 510(k) clearance, MDD, and MDR regulatory standards, ensuring compliance with international medical device directives. No specific sterility or single-use designation is stated in the data.
Frequently asked questions
What are the Sonosite ultrasound systems designed for?
These portable diagnostic imaging devices are designed for real-time visualization of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes across various clinical settings.
In which clinical environments are these ultrasound systems intended to be used?
They are intended for use in clinical environments including emergency departments, intensive care units, and procedural rooms where portability and rapid imaging are critical.
Are these ultrasound systems single-use devices?
No, these systems are supplied as reusable medical devices that require adherence to manufacturer cleaning and sterilization protocols.
What regulatory standards do these Sonosite ultrasound systems comply with?
Each model adheres to FDA 510(k) clearance, MDD, and MDR regulatory standards, ensuring compliance with international medical device directives.
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 | K202160 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
Sources (2)
- FDA 510(k) K202160 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026