SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM
FDA premarket approval P010038/S012 · decided 2008-04-04
Approval details
- PMA number
- P010038
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2006-07-12
- Decision date
- 2008-04-04
- Days to decision
- 632 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR THE USE OF THE SECONDLOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY WITH FUJI MEDICAL SYSTEMS COMPUTED RADIOGRAPHY MAMMOGRAMS (CRM). THE DEVICE IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM FUJIFILM MEDICAL SYSTEMS COMPUTED RADIOGRAPHY SYSTEM (FUJI CRM) TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER AN INITIAL READING HAS BEEN COMPLETED.
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