The U.S. Securities and Exchange Commission has filed fraud charges against a medical imaging firm and its CEO, charging that the CEO made misleading comments about a scanner rejected by the U.S. Food and Drug Administration during a shareholder call.

The SEC said Wednesday that during a November 2010 conference call with shareholders, Dean Janes, founder, chairman and CEO of Burbank, Calif.-based Imaging3 Inc., misled shareholders about the FDA's view of the company's medical device.

According to the complaint, in addition to selling, renting and servicing remanufactured or refurbished mobile imaging devices, the company has made repeated unsuccessful attempts to obtain FDA approval for a medical imaging device known as the Dominion Volumetric Scanner to produce 3D medical diagnostic images in real time.

The SEC said in its complaint, which was filed Tuesday in the U.S. District Court in Los Angeles, that a key component of the company's business plan and its ability to generate a profit depends upon its ability to market and sell the Dominion Scanner.

The SEC said in its statements that Mr. Janes' conference call was held after the FDA denied clearance for the third time for Imagine3 to market its scanner.

The SEC said Mr. Janes did not discuss issues raised by the FDA in an October 2010 letter, such as the device's potential for overheating, and the fact that some sample images the company submitted were “scientifically invalid and useless.”

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According to the SEC, even when asked on the call whether any of the FDA's concerns were safety-related or involved image quality, he responded, “Nope,” and said there was “really and honestly not one question about the technology or its consistency. It just doesn't make sense to me.”

The SEC said after an investor obtained the FDA's denial letter and posted it on a blog in early 2011, Mr. Janes used his personal Facebook page to mischaracterize the denial, and he and his company did not officially issue the full text of the denial letter until earlier this year, more than two years after the conference call.

The SEC charges the company and Mr. Janes with fraud and seeks a court order to bar them from future violations of federal securities laws, require them to pay civil monetary penalties, and bar Mr. Janes from serving as a public company officer or director.

“Shareholders have a right to trust corporate officers to tell them the truth about the business. When CEOs abuse that trust and make misstatements, innocent shareholders are victimized,” said Michele Wein Layne, regional director of the SEC's Los Angeles Regional Office, in a statement. “The SEC will hold corporate officers accountable for misleading shareholders.”

A defense attorney in the case had no comment.