Imaging Diagnostic Systems Release: The CTLM is a New and Unique Imaging Technology Best Described as 'Diffuse Optical Tomography' (DOT)
Published: Aug 09, 2011
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Imaging Diagnostic Systems, Inc., (IDSI) (OTCBB:IMDS) a pioneer in optical breast imaging announced that it has received notification from the Food and Drug Administration (FDA) that the review of the company's Section 510(k) pre-market notification application of its CTLM system has been completed and categorized as a Class III device requiring a Premarket Approval application. The FDA determined that the CTLM device “is not substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, or to any device which has been reclassified into a class I (General Controls) or class II (Special Controls) or to any device found to be substantially equivalent through the 510 (k) process. The FDA concluded that the CTLM device is classified by statute into a Class III device which requires a Premarket Approval (PMA) application. The company has begun the process to submit a PMA application to the FDA.