FDA grants 510(k) clearance for Escalon?s ultrasound system

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Escalon Medical has received 510(k) clearance from the FDA to market the VascuView visual ultrasound system for use with assisted vascular access.

The VascuView visual ultrasound system utilizes a tablet PC with software built on the Microsoft Windows XP platform, according to the Wayne, Pa.-based Escalon. The probe contains the ultrasound circuitry and connects via a USB-2 interface. The company said that the system includes: an image display; a touch-screen display; scan operation controls on the probe itself; visualization of depth to 6 cm; and software tools such as calipers and needle-guide overlay.

The company’s subsidiary, Escalon Vascular Access, said it plans to commence shipments of the product in the United States immediately.