HER2 Support Group Forums - View Single Post - IDSI submits Premarket Notification for CTLM breast imaging device to FDA

News · 11-23-2010, 10:00 PM

Imaging Diagnostic Systems, Inc., a pioneer in laser breast imaging, announced today that a Premarket Notification 510(k) was submitted on Monday, November 22, 2010, to the United States Food and Drug Administration (FDA). With this submission, the company moves forward in the process of seeking marketing clearance for its innovative breast imaging device, the CTLM system.

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11-23-2010, 10:00 PM	#1
News Senior Member Join Date: Oct 2007 Posts: 18,982	IDSI submits Premarket Notification for CTLM breast imaging device to FDA Imaging Diagnostic Systems, Inc., a pioneer in laser breast imaging, announced today that a Premarket Notification 510(k) was submitted on Monday, November 22, 2010, to the United States Food and Drug Administration (FDA). With this submission, the company moves forward in the process of seeking marketing clearance for its innovative breast imaging device, the CTLM system. More...