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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceM-VU ALGORITHM ENGINE
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantICAD, INC.
98 SPIT BROOK ROAD
SUITE 100
NASHUA, NH 03062
PMA NumberP100005
Date Received02/01/2010
Decision Date01/23/2012
Reclassified Date 02/21/2020
Product Code MYN 
Docket Number 12M-0082
Notice Date 01/26/2012
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S002  S001 S007 S003 S004 S005 
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