3D imaging device developer Imaging3 of Burbank, CA, announced it will resubmit an application to the U.S. Food and Drug Administration (FDA) under the FDA's 510(k) process for its Dominion volumetric imaging scanner (DViS).
The company revealed that under advisement of counsel, minor adjustments to the existing package plus a potential presubmission meeting with the FDA should improve chances of clearance.
The scanner employs fluoroscopy technology to produce 3D images in real-time, according to the company.
Related Reading
Imaging3 to debut 3D software at RSNA show, November 21, 2008
Road to RSNA, Digital X-Ray, Imaging3, October 22, 2008
Imaging3 gets FDA IDE, April 2, 2008
Road to RSNA, Digital X-Ray, Imaging3, October 23, 2007
Imaging3 files 510(k) for Dominion 3D, June 19, 2007
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