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. |
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Device | M-VU ALGORITHM ENGINE |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 NASHUA, NH 03062 |
PMA Number | P100005 |
Date Received | 02/01/2010 |
Decision Date | 01/23/2012 |
Reclassified Date
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02/21/2020 |
Product Code |
MYN |
Docket Number | 12M-0082 |
Notice Date | 01/26/2012 |
Advisory Committee |
Radiology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE M-VU ALGORITHM ENGINE. THE DEVICE IS INDICATED FOR USE IN SCREENING MAMMOGRAPHY TO IDENTIFY AREAS CONSISTENT WITH BREAST CANCER FOR RADIOLOGIST REVIEW AFTER COMPLETING AN INITIAL READ. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S007 |
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