Imaging3 gains FDA distribution approval
Imaging3 has received FDA 510(k) clearance to distribute the Dominion Vi Scanner, a medical imaging device that produces 3D diagnostic images of the body in real-time.
"This approval to distribute the Dominion Vi Scanner is for investigational purposes only allowing the company to glean clinical imagery and functionality during the FDA 510(k) approval process,” said Dean Janes, chairman and CEO of Imaging3.
The Dominion can be utilized for both diagnostic and interventional procedures, in a variety of clinical areas including trauma, pain management, pediatrics, orthopedics, sports medicine, cardiovascular imaging and neuro-vascular imaging, according to the Burbank, Calif.-based company.
"This approval to distribute the Dominion Vi Scanner is for investigational purposes only allowing the company to glean clinical imagery and functionality during the FDA 510(k) approval process,” said Dean Janes, chairman and CEO of Imaging3.
The Dominion can be utilized for both diagnostic and interventional procedures, in a variety of clinical areas including trauma, pain management, pediatrics, orthopedics, sports medicine, cardiovascular imaging and neuro-vascular imaging, according to the Burbank, Calif.-based company.