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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Generic Namesystem,image processing,radiological
ApplicantHOLOGIC, INC.
PMA NumberP030012
Date Received04/16/2003
Decision Date07/08/2004
Conversion Date 12/21/2007
Product Code
NRR[ Registered Establishments with NRR ]
Docket Number 04M-0323
Notice Date 07/22/2004
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the imagechecker ct cad software system - model ln-1000. This software system is indicated to assist radiologists in the detection of solid pulmonary nodules during review of multidetector ct (mdct) scans of the chest. It is intended to be used as an adjunct, alerting the radiologist - after his or her initial reading of the scan - to regions of interest (rois) that may have been initially overlooked.
Approval Order Approval Order