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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceIMAGECHECKER CT CAD SOFTWARE SYSTEM
Generic NameLung computed tomography system, computer-aided diagnosis
ApplicantHologic, Inc.
35 Crosby Dr.
Bedford, MA 01730
PMA NumberP030012
Date Received04/16/2003
Decision Date07/08/2004
APCB Date12/21/2007
Product Code NRR 
Docket Number 04M-0323
Notice Date 07/22/2004
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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