Hologic gets 510(k) for entry-level mammography system

While it awaits FDA premarket approval for its full-field digital mammography system, Hologic of Bedford, MA, has received 510(k) clearance of an entry-level film-screen product, Lorad Affinity.

Lorad Affinity has performance characteristics similar to that of high-end systems, the company said, and features Lorad’s high-transmission cellular grid technology and fully automatic self-adjusting tilt compression paddle.

The company expects full commercial production of Affinity to begin in the first quarter of 2002.

By AuntMinnie.com staff writers
November 1, 2001

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Hologic gets FFDM approvable letter, October 26, 2001

Is full-field digital mammography worth its weight in gold?, October 22, 2001

BIC presenter offers ways to reduce false-positive breast biopsies, October 16, 2001

Mammography market stands at crossroads, September 25, 2001

Hologic's new CEO takes aim at digital mammography, September 18, 2001

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