Philips receives FDA 510(k) clearance for its innovative ultra mobile VISIQ ultrasound system

July 8, 2014

Transducer-plus-tablet display delivers excellent image quality, making ultrasound available anytime, in a wide range of clinical environments for OB patients


ANDOVER, MA – Royal Philips (NYSE: PHG AEX: PHIA) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its innovative ultra-mobile ultrasound system, VISIQ, in the U.S.VISIQ is the first Philips ultrasound system to combine the benefits of greater mobility, performance and simplicity into a single miniaturized solution, helping clinicians increase access to quality diagnostic scans for more OB patients.


This breakthrough ultrasound device can be easily transported wherever care is needed, and its quick-start technology and long battery life make it an ideal system for physician offices, hospitals and other clinical settings.


“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 a multiple locations or schedule return visits,” said Vitor Rocha, CEO, Ultrasound, for Philips. “VISIQ is the latest example of Philips continued commitment to create advanced innovative technology solutions to deliver better care at lower cost to help improve patient outcomes.”


VISIQ’s touch-screen gesture controls are familiar to anyone who has used a smartphone or tablet. It allows users to easily capture images, take measurements and share data. In addition, VISIQ offers many of the same automatic image optimization features found on Philips’ premium EPIQ systems, as well as built-in Wi-Fi for DICOM data transfer to hospital or cloud-based PACS.


At the heart of the VISIQ system is a smart transducer that fits comfortably into the user’s hand. Drawing on more than 30 years of experience in ultrasound, Philips has taken advantage of advances in miniaturization to integrate a sophisticated broadband micro-digital beam former and powerful image acquisition module into the transducer. VISIQ targets OB and abdominal applications and lays the foundation for a future range of portable ultrasound products to meet the evolving needs of clinicians and patients.


“Portable and convenient, VISIQ is so intuitive, with remarkable, easy-to-use measurement capabilities for maternal fetal medicine specialists or general obstetricians,” said Dr. Michael Ruma, maternal–fetal medicine specialist at Perinatal Associates of New Mexico. “Instead of just listening to the baby’s heartbeat, clinicians are able to see the baby in 2D and color, providing peace of mind and excitement to the expectant parent and to the patient.”


VISIQ is also commercially available in Burundi, China, Ethiopia, France, Germany, India, Kenya, Rwanda, Tanzania and Uganda.


For more information on VISIQ and the full suite of Philips innovative ultrasound solutions, visit:

For further information, please contact:

Leslie Lakis

Philips Healthcare Communications, Imaging Systems

Tel: +1 (978) 659-3748






About Royal Philips:

Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people’s lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2013 sales of EUR 23.3 billion and employs approximately 115,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at


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