About FUJIFILM VisualSonics

About FUJIFILM VisualSonics

FUJIFILM VisualSonics, a wholly owned subsidiary of FUJIFILM Sonosite, designs and manufactures Ultra High Frequency ultrasound imaging systems, for both research and clinical use.

FUJIFILM VisualSonics specifically focuses on Ultra High Frequency (UHF) ultrasound machines. For the first 3cm of a scanned body, UHF ultrasound provides images at much higher resolutions—as fine as 30μm—than other imaging systems currently available.

Regulatory Documents

US/Canada European Union All Other Countries Safety/EMC
Sonosite is comprised of an innovative team of professionals with many years of experience in medical diagnostic ultrasound technology. Sonosite is at the forefront of defining a world-class standard of quality management for ultrasound manufacturing. Sonosite, Inc. is an FDA registered firm as a specification developer and manufacturer of medical devices.

Sonosite products are designed, manufactured, and distributed in full accordance with the requirements of FDA’s Quality System Regulation. We are regularly inspected by BSI - the British Standards Institute, which is Sonosite’s European “notified body” under the medical device directive. Regulatory documents for both individual devices and Sonosite’s quality management system are available.
 

United States/Canada

The 510(k) pre-market notification process is the most common method used in the United States for describing the design and manufacture of medical devices which the US Food and Drug Administration (FDA) uses to determine a "substantial equivalence" decision to authorize marketing of a medical device within the United States.

Safety/EMC/Regulatory

Sonosite products are tested for compliance to internationally recognized standards for electromedical equipment safety and electromagnetic compatibility (EMC). Compliance documents for Sonosite’s devices are available. Use the links below to view them.

Product Name:
Sonosite X-Porte Ultrasound System

Trade Names:
Sonosite X-Porte Ultrasound System

Documents:

Product Name:
Sonosite Edge Ultrasound System

Trade Names:
Sonosite Edge® Ultrasound System

Global Health Loaner Pool

Sonosite is thrilled to lend portable ultrasound machines to U.S.-based physicians and ultrasound-trained healthcare workers engaged in humanitarian work in developing countries around the world. To support these non-profit medical missions, Sonosite lends portable ultrasound machines to qualified clinicians for an average of 2 weeks at a time.

The 500Hearts team and local assistants scanned hundreds of children with a loaned Sonosite MicroMaxx ultrasound in the Cambodian Village of Sophy.

Why Choose Sonosite: Reliability

Reliability means you have one less thing to worry about, because the technology does what you want it to when you want it to.

In point-of-care ultrasound, Sonosite equipment is the measure of reliability. It has been developed and tested in the field by the professionals who require the benefits of ultrasound at a moments notice, and who want to make sure they achieve the same results over and over again.

It is no accident that medical professionals around the world have come to rely on Sonosite. Trust is at the heart of our relationship with the clinicians whose work demands performance at critical times. A system failure isn’t just an annoyance, it may mean the difference between life and death.

Sonosite means reliability.

Find out more about the lengths we go to in making sure you can count on your Sonosite machine by downloading the free reliability infographic

Why Choose Sonosite: Ease of Use

The practise of medicine is hard enough. The last thing you need is an ultrasound machine you can’t figure out how to use.

At Sonosite, one of our greatest technical achievements is ease-of-use. When you want to know what’s going on, or how to proceed, Sonosite makes point-of-care ultrasound that won’t block you with technical obstacles that slow you down. You get what you need, when and where you need it, so that you can provide your patient with the optimal care path.

Making it easy for you to do your job better is simply the Sonosite way.

To find out how our customers play a key role in our product development process, download the free infographic.