IMAGECHECKER M1000 SYSTEM
FDA premarket approval P970058/S002 · decided 1999-01-16
Approval details
- PMA number
- P970058
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMAGECHECKER M1000 SYSTEM
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 1998-10-01
- Decision date
- 1999-01-16
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for new software that significantly reduces extraneous marks while providing a modest increase in sensitivity for detecting of masses.
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