IMAGE CHECKER M1000 SYSTEM
FDA premarket approval P970058/S008 · decided 2000-07-05
Approval details
- PMA number
- P970058
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMAGE CHECKER M1000 SYSTEM
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 2000-06-01
- Decision date
- 2000-07-05
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- APPROVAL FOR THE ADDITION OF A NEW MASS MARKER. THIS MARKER (A CIRCLE) IS INTENDED TO ENABLE THE USER OF THE IMAGECHECKER TO DIFFERENTIATE OBVIOUS MASSES FROM MORE SUBTLE MASSES THAT APPEAR IN ANALYZED MAMMOGRAMS.
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