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[3RunHomer]

This is from April 2008 so don't get too excited from the headline.

REGULATORY NEWS
Imaging3 gains FDA distribution approval
Written by Editorial Staff April 4, 2008


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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.

Last updated on April 9, 2008 at 4:58 am EST

AND more old news from Feb 2007

TOP STORIES
Imaging3 gets first Dominion install
Written by Editorial Staff February 23, 2007


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Imaging3 has closed a deal to make Oregon Health & Science University in Portland, Oregon the first luminary sites for the company’s Dominion device. Other sites are planned for the near future, the company said.

OHSU is a public university that houses two of the state’s largest hospitals, Oregon Health & Science University Hospital and Doernbecher Children’s Hospital, in addition to a number of outpatient and research facilities. OHSU in known for a number of clinical and research breakthroughs in the areas of cancer, children’s health, computer technology, genetics, trauma care, heart disease, hearing, infectious disease, general medicine, reproduction, mental health, interventional radiology, neurosciences, nursing, and others.

Imaging3 develops medical imaging devices capable of producing 3D medical diagnostic images of nearly any portion of the body in real-time, the company said.

Can someone help me with this.

Is the above mentioned Dominion Vi Scanner (DViS ?) the same device that we are waiting FDA approval for?...and, how could there be a contract for a luminary site in 2007?

Was this device installed and used to " glean clinical imagery and functionality during the FDA 510(k) approval process,” said Dean Janes, chairman and CEO of Imaging3.