SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
FDA premarket approval P010034/S004 · decided 2003-10-31
Approval details
- PMA number
- P010034
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2003-05-30
- Decision date
- 2003-10-31
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR THREE USER PREFERRED THRESHOLD SETTINGS FOR THE PERFORMANCE OF SECOND LOOK ANALOG 6.0 CAD SYSTEM, UPDATED CAD ALGORIGHMS TO INCREASE SENSITIVITY, AND NEW UPDATED COMMERCIAL DATABASE DRIVER FOR IMPROVED SPEED AND RELIABILITY FOR THE SYSTEM.
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