Sonosite Maxx Series Ultrasound System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130173 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 Maxx Series Ultrasound System is a portable 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 clinicians to assess organs, tissues, and blood flow for diagnostic purposes. Designed for versatility, this system supports a range of applications, including musculoskeletal, abdominal, vascular, and cardiac evaluations. Its compact and mobile design facilitates point-of-care use in diverse clinical settings.
The system is supplied as a reusable medical device, intended for use in clinical environments such as emergency departments, intensive care units, and outpatient clinics. It operates with standard electrical power and battery options, ensuring flexibility for on-site and mobile diagnostics. The device adheres to FDA 510(k) clearance and MDD (Medical Device Directive) requirements, with a Substantially Equivalent determination under the Radiology Advisory Committee. No specific sterility or single-use designation is noted, and MRI safety information is not provided in the specifications.
Frequently asked questions
Is the Sonosite Maxx Series Ultrasound System designed for single-use or can it be reused in a clinical setting?
The Sonosite Maxx Series is explicitly described as a reusable medical device, intended for use in clinical environments like emergency departments, intensive care units, and outpatient clinics. Since no sterility or single-use designation is mentioned, it is meant for repeated use within a facility, provided proper cleaning and maintenance protocols are followed.
What types of diagnostic evaluations can this ultrasound system perform, and why is its portability important?
The Sonosite Maxx Series supports a broad range of applications, including musculoskeletal, abdominal, vascular, and cardiac evaluations, enabling clinicians to visualize internal structures and blood flow in real time. Its compact and mobile design makes it ideal for point-of-care use, allowing quick assessments in diverse settings—such as emergency rooms or mobile clinics—where traditional imaging systems may not be practical.
How is the Sonosite Maxx Series powered, and what flexibility does this provide for clinical use?
The system operates using standard electrical power as well as battery options, ensuring flexibility for both stationary and mobile diagnostics. This dual-power capability allows clinicians to perform imaging in locations without reliable outlets, such as ambulances, remote clinics, or disaster response scenarios, without compromising functionality.
What regulatory pathways does the Sonosite Maxx Series follow, and how does this affect its use in different markets?
The device holds FDA 510(k) clearance under the Radiology Advisory Committee, with a determination of Substantially Equivalent (SESE) to a predicate device. It also complies with the Medical Device Directive (MDD) in European markets. These pathways confirm its safety and performance for diagnostic ultrasound imaging, ensuring it meets regulatory standards for use in the U.S. and EU, though specific country requirements (e.g., CE marking) should be verified locally.
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, Sonosite MicroMaxx | FUJIFILM Sonosite
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 | K130173 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
Sources (2)
- FDA 510(k) K130173 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026