ICAD
FDA premarket approval P010038/S001 · decided 2003-02-24
Approval details
- PMA number
- P010038
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ICAD
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2002-10-28
- Decision date
- 2003-02-24
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR USE OF THE 3.9.3.7 VERSION OF THE SOFTWARE. THE NEW SOFTWARE IS INTENDED TO IMPROVE THE OVERALL SENSITIVITY, IMPROVE THE BREAST SEGMENTATION PROCESS, REDUCE THE FALSE MARKER RATE AND IMPROVE THE OVERALL CONSISTENCY OF THE ALGORITHM. THE CLINICAL PERFORMANCE CLAIMS ARE NOT CHANGED.
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