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CTLM® Intended Use
![]() The CT Laser Mammography is a revolutionary device that can image the human breast to determine if cancer may be present. The CTLM is unique because it uses no x-radiation—only laser light—to create a 3D image. Unlike x-ray mammo, the CTLM never compresses or even touches the breast making the entire exam easy and painless. IDSI will be applying for FDA approval to sell and market the device in the USA. In the meantime we are marketing the product in many other countries where approvals have already been granted. Our "intended use" will support our premise that CT Laser Mammography is designed to be an adjunct to mammography to help reduce the number of negative (and unnecessary) breast biopsies. In the future, we believe laser optical breast scanning may be a primary method of diagnostic imaging response to therapy. | ||||||||||||||||
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All Specifications Subject To Change Without Notice. Investigational Device Limited. By Federal Law For Investigational Use. | |||||||||||||||||