SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
FDA premarket approval P010038/S009 · decided 2005-03-07
Approval details
- PMA number
- P010038
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Other
- Trade name
- SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2005-01-18
- Decision date
- 2005-03-07
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR PRIVATE LABEL DISTRIBUTION (HOLOGIC, INC. TO DISTRIBUTE SECOND LOOK). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECURLOOK AND IS INDICATED FOR: THE SECURLOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED. THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVE
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