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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSECOND LOOK (TM)
Classification Nameanalyzer,medical image
Generic Namecomputer-aided detection system for mammography
ApplicantICAD, INC.
PMA NumberP010034
Date Received06/11/2001
Decision Date01/31/2002
Withdrawal Date 04/08/2011
Product Code
MYN[ Registered Establishments with MYN ]
Docket Number 01M-0060
Notice Date 02/07/2002
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 S005 
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