SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
FDA premarket approval P010034/S005 · decided 2003-10-08
Approval details
- PMA number
- P010034
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2003-10-03
- Decision date
- 2003-10-08
- Days to decision
- 5 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR THE USE OF THE SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY WITH THE FISHER IMAGING'S SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
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