The FDA has notified Imaging Diagnostic Systems that the review of its Section 510(k) premarket notification application of its CTLM system has been completed and categorized as a Class III device requiring a premarket approval (PMA) application.
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.”
FDA concluded that the CTLM device is classified by statute into a Class III device which requires a PMA application. The company has begun the process to submit a PMA application to the FDA.
Linda Grable, chair and CEO of Fort Lauderdale, Fla.-based Imaging Diagnostic Systems, commented, “The FDA conclusions are somewhat disappointing but also very encouraging. In that, on the one hand, we are disappointed that the FDA found more dissimilarities rather than similarities between CTLM, MRI and CT even though CTLM has its technological roots deeply based on both CT and MRI imaging theory. However, on a very positive note, after years of developing a truly unique and non-invasive breast imaging technology, we are finally being recognized as 'Diffuse Optical Tomography.' As a new and maybe the first DOT imaging device to seek FDA approval, we are now more dedicated to meeting all of the FDA approval requirements as quickly as possible.”