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Analogic obtains FDA 510(k) approval for Sonic Window ultrasound system

Analogic, a medical device company, has obtained 510(k) approval from the the US Food and Drug Administration’s (FDA) for its Sonic Window ultrasound system.

Sonic Window ultrasound system is a handheld portable device intended for visualizing vasculature and guiding peripheral intravenous access. It is based on DSIQ technology and incorporates an advanced 2D ultrasound imaging array.

Analogic’s Sonic Window system effectively guides clinicians to place peripheral IVs by providing direct visualization of structures beneath the skin in real time. The self-contained device does not have cables and wires connecting a transducer, and it does not require a cart or stand to operate.

Analogic president and CEO Jim Green noted that the Sonic Window provides clinicians with accurate depth measurement, allowing them to choose the appropriate catheter size and length.

"We are confident that the innovative Sonic Window handheld will offer clinicians a valuable tool for vascular access applications. The FDA clearance supports our previously announced plan to begin shipments later this summer.

"We also expect that the Sonic Window platform will form the foundation of a family of products that will address procedure guidance and diagnostic needs in both acute care and physician offices," Green added.

The portable, lightweight device has a rechargeable battery and does not need to be plugged in to operate. The device is in the size of a TV remote control and requires only one hand to operate.

During scanning, the system’s controls may be manipulated without any interruption to the image on the screen.