Breast gamma camera cleared by FDA

IS2 Research of Nepean, Ontario has been given 510(k) clearance by the FDA for BCC, a dedicated breast cancer gamma camera. The scintimammography camera is to be used as an adjunct to x-ray mammography.

BCC is an ultra-high-resolution gamma camera that can identify lesions of 5 mm or less, according to the company. Using stereotactic imaging, BCC can locate the lesions in 3-D. Both breasts can be imaged simultaneously while the patient lies face down on a dedicated breast imaging table. A customized collimator assists in separating breast tissue from the chest wall.

By AuntMinnie.com staff writers
February 18, 2002

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