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

AuntMinnie.com staff writers

Oct 31, 2001

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
Related Reading

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

Copyright © 2001 AuntMinnie.com

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