Imaging Diagnostic Systems (fka IMDS)

[jmurfk]

510k was rejected in August 2011. I guess there is some confused folks, claiming FDA approval is coming, since they think there is a 510k application submitted to the FDA. From the last quarterly, released 2 months ago, page 56, it states that 510 was rejected almost a year ago. It goes on to explain they will require a PMA application now. As of the quarterly, 2 months ago, they are months from submission.

On August 2, 2011, we received official notification from the FDA that the review of our Section 510(k) premarket notification application had been completed and that the FDA determined that the device, (CTLM®), is not substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to any device which has been reclassified into Class I (General Controls) or Class II (Special Controls), or to another device found to be substantially equivalent through the Section 510(k) process.  Although the FDA did not use the term “rejected” in the NSE letter, the effect of this letter is that our Section 510(k) premarket notification of intent to market the device (CTLM®) has been rejected.  Therefore, this device was classified by statute into class III (Premarket Approval), under Section 513(t) of the Federal Food, Drug, and Cosmetic Act (the “Act”).  All FDA determined Class III devices must fall under Section 515(a)(2) of the Act (which) requires a class III device to have an approved application (PMA) before it can be legally marketed.