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