510(k) Clearance from the FDA

Handheld ultrasound medical device manufacturer, Signostics, has received a major boost with 510(k) clearance from the US Food and Drug Administration (FDA) to market its new Signos RT to the American market.

510(k) clearance from the FDA means the widely acclaimed Signos RT can now be sold throughout the US where it will be marketed as the “Sonimage P3” – the brand name of Signostics’ newly appointed global partner Konica Minolta Inc.

“FDA clearance for the USA market further enhances the potential of this innovative product and will enable medical practitioners and patients throughout America to benefit from the real-time point-of-care imaging capabilities that the device provides,” states Warren Ortmann, CEO, Signostics. “This clearance will help us build on the enormous interest we have already received from potential distribution partners throughout Europe, South East Asia and our own Australian market who have seen and experienced the device first-hand.

“It certainly is a very important and exciting milestone for Signostics and is a fantastic boost for our new distribution partnership with Konica Minolta.”

The Signos RT / Sonimage P3 device features unique patented technology and an awardwinning design to provide a lightweight handheld ultrasound device for high quality imaging at the point-of-care for medical practitioners, healthcare professionals, and veterinarians globally across a broad range of clinical settings.

The US FDA is responsible for protecting and promoting public health through the regulation and supervision of consumer products including medical devices. It administers section 510(k) clearances of the Food, Drug and Cosmetics Act which enable manufacturers to introduce new products to the US market for commercial distribution.

Earlier this year, Signostics and Konica Minolta announced a key distribution partnership which sees Konica Minolta selling the Signos RT / Sonimage P3 device exclusively through Japan, China, India and the USA.