| 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 |
|---|
| Generic Name | Analyzer, medical image |
|---|
| Regulation Number | 892.2070 |
|---|
| Applicant | Icad, Inc.
98 Spit Brook Rd., Suite 100
Nashua, NH 03062 |
|---|
| PMA Number | P010038 |
|---|
| Date Received | 07/19/2001 |
|---|
| Decision Date | 01/15/2002 |
|---|
| Reclassified Date | 02/21/2020 |
|---|
| Product Code |
MYN |
| Docket Number | 02M-0030 |
|---|
| Notice Date | 01/22/2002 |
|---|
| Advisory Committee |
Radiology |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
Approval Order Statement
APPROVAL FOR THE MAMMOREADER. THE MAMMOREADER IS A COMPUTER SYSTEM 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 |
|---|
| Labeling | Labeling
|
|---|
| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012
S013 S014 S015 S016 S017 |
|
|
