PMA P010038S009
- Device
- SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
- Applicant
- Icad, Inc.
- PMA number
- P010038
- Supplement
- S009
- Product code
- MYN
- Decision date
- 2005-03-07
- Classification
- Analyzer, Medical Image
- Generic name
- Analyzer, medical image
- Approval order 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 OVERSIGHTS BY IDENTIFYING AREAS OF THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
Current openFDA PMA Record#
- Device
- SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
- Applicant
- Icad, Inc.
- PMA number
- P010038
- Supplement
- S009
- Product code
- MYN
- Generic name
- Analyzer, medical image
- Decision date
- 2005-03-07
- Decision code
- APPR
- Date received
- 2005-01-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Other
- Approval order 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 OVERSIGHTS BY IDENTIFYING AREAS OF THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.