The Netherlands-based Royal Philips has obtained 510(k) clearance from the US Food and Drug Administration for its VISIQ ultra mobile ultrasound system, clearing the sale of the device in the country.


VISIQ ultrasound system claimed to offer greater mobility, performance and simplicity into a single miniaturized solution for diagnostic scans of obstetric patients.

The ultrasound system targets obstetric and abdominal applications and lays the foundation for a future range of portable ultrasound products.

Philips Healthcare Imaging Systems CEO Gene Saragnese said: "VISIQ marks a new vision in ultrasound for Philips by allowing physicians to perform on-the-spot diagnostic scans, limiting the need for patients to go to multiple locations or schedule return visits.

"VISIQ is the latest example of Philips’ continued commitment to create advanced innovative technology solutions to deliver better care at lower cost and to help improve patient outcomes."

VISIQ features a smart transducer that fits comfortably into the user’s hand. The ultrasound system incorporates quick-start technology and long battery life.

Users can easily capture images, take measurements and share data with the VISIQ system. The device also offers many of the automatic image optimization features found on Philips’ EPIQ system, as well as built-in Wi-Fi for DICOM data transfer to hospital or cloud-based PACS.

The transducer-plus-tablet display delivers excellent image quality, making ultrasound available anytime, in a wide range of clinical environments for obstetric patients.

The VISIQ ultrasound system is also commercially available in China, East Africa, France, Germany and India.

Image: Philips receives FDA 510(k) clearance for its innovative ultra mobile VISIQ ultrasound system. Photo: Courtesy of PRNewswire/ Royal Philips