PMA P970058S009

Device: PROMINENT CALC FEATURE MARKER
Applicant: Hologic, Inc.
PMA number: P970058
Supplement: S009
Product code: MYN
Decision date: 2001-01-22
Generic name: Analyzer, medical image
Approval order statement: APPROVAL FOR THE ADDITION OF A NEW CALCIFICATION MARKER. THIS MARKER (A CIRCLE) IS INTENDED TO ENABLE THE USER OF THE IMAGECHECKER TO DIFFERENTIATE OBVIOUS CALCIFICATIONS FROM MORE SUBTLE CALCIFICATIONS THAT APPEAR IN ANALYZED MAMMOGRAMS.

Current openFDA PMA Record#

Device: PROMINENT CALC FEATURE MARKER
Applicant: Hologic, Inc.
PMA number: P970058
Supplement: S009
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2001-01-22
Decision code: APPR
Date received: 2000-12-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF A NEW CALCIFICATION MARKER. THIS MARKER (A CIRCLE) IS INTENDED TO ENABLE THE USER OF THE IMAGECHECKER TO DIFFERENTIATE OBVIOUS CALCIFICATIONS FROM MORE SUBTLE CALCIFICATIONS THAT APPEAR IN ANALYZED MAMMOGRAMS.