Imaging3 files with Federal Drug Administration 510(k) application filed with FDA on June 15
Tuesday, 30 November 1999 00:00 | 
| Imported - Imported |
Imaging3, developer of a breakthrough medical imaging device that produces 3D medical diagnostic images, submits the Dominion 3D real-time imaging device to the FDA.
Imaging3, developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, has announced that the company has filed it's 510(k) submission for the Dominion 3D real-time imaging device with the FDA on June 15.
"I'm pleased to announce that Imaging3 has met its filing deadline for submission of the Dominion real-time imaging device to the FDA for their approval," states Mr. Dean Janes Chairman and CEO of Imaging3. Mr. Janes added this critical milestone represents the start of a new phase in Dominion's development and brings Imaging3 one step closer to delivering this technology to the healthcare marketplace.
Mr. Janes noted that this will be the fourth Fluoroscopy based imaging device that he has personally navigated through the 510(k) submission process. "Based on our previous experience we believe that we have a good understanding of what the FDA needs to see in the submission and we have kept those needs at the forefront throughout the Dominion's development", adds Mr. Janes. "While there are no guarantees on how long this process can take, we have done everything in our power to deliver as much data as possible."
About Imaging3
Imaging3, Inc., founded in 1993, is a leading provider of advanced technology medical imaging devices. The company has developed a breakthrough technology (patented) that will produce 3D medical diagnostic images in real-time.
Because these 3D images are instantly constructed in real-time, they can be used for any current or new medical procedures in which multiple frames of reference are required to perform medical procedures on or in the human body.
Imaging3 Technology can to contribute to the improvement of healthcare. By providing this higher quality and quantity of information, the physician or clinician will be able to perform any procedure with a higher level of accuracy while decreasing the time spent performing the procedure.
By increasing throughput while increasing diagnostic and clinical accuracy, Imaging3 Technology becomes an attractive new technology that will provide healthcare centers with a high return on investment.
"I'm pleased to announce that Imaging3 has met its filing deadline for submission of the Dominion real-time imaging device to the FDA for their approval," states Mr. Dean Janes Chairman and CEO of Imaging3. Mr. Janes added this critical milestone represents the start of a new phase in Dominion's development and brings Imaging3 one step closer to delivering this technology to the healthcare marketplace.
Mr. Janes noted that this will be the fourth Fluoroscopy based imaging device that he has personally navigated through the 510(k) submission process. "Based on our previous experience we believe that we have a good understanding of what the FDA needs to see in the submission and we have kept those needs at the forefront throughout the Dominion's development", adds Mr. Janes. "While there are no guarantees on how long this process can take, we have done everything in our power to deliver as much data as possible."
About Imaging3
Imaging3, Inc., founded in 1993, is a leading provider of advanced technology medical imaging devices. The company has developed a breakthrough technology (patented) that will produce 3D medical diagnostic images in real-time.
Because these 3D images are instantly constructed in real-time, they can be used for any current or new medical procedures in which multiple frames of reference are required to perform medical procedures on or in the human body.
Imaging3 Technology can to contribute to the improvement of healthcare. By providing this higher quality and quantity of information, the physician or clinician will be able to perform any procedure with a higher level of accuracy while decreasing the time spent performing the procedure.
By increasing throughput while increasing diagnostic and clinical accuracy, Imaging3 Technology becomes an attractive new technology that will provide healthcare centers with a high return on investment.
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