| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
| |
| Device | SECOND LOOK (TM) |
|---|
| Generic Name | Analyzer, medical image |
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| Regulation Number | 892.2070 |
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| Applicant | ICAD, INC.
98 SPIT BROOK ROAD
SUITE 100
NASHUA, NH 03062 |
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| PMA Number | P010034 |
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| Date Received | 06/11/2001 |
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| Decision Date | 01/31/2002 |
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|
Withdrawal Date
|
04/08/2011 |
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| Product Code |
MYN |
| Docket Number | 01M-0060 |
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| Notice Date | 02/07/2002 |
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| Advisory Committee |
Radiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE SECOND LOOK. COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS 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 ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 S003 S004 S005 |
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|
