IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0
FDA premarket approval P970058/S020 · decided 2005-02-17
Approval details
- PMA number
- P970058
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 2004-06-29
- Decision date
- 2005-02-17
- Days to decision
- 233 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- APPROVAL FOR IMPROVEMENTS IN THE CAD DETECTION ALGORITHM AND THE INTRODUCTION OF MORE CHOICE IN OPERATING POINTS FOR BOTH ANALOG AND DIGITAL IMAGES.
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