Imagechecker CT Cad Software System

FDA premarket approval P030012 · Lung computed tomography system, computer-aided diagnosis

PMA numberP030012

Approval

Applicant
Hologic, Inc.
Received
April 16, 2003
Decision date
July 8, 2004 (APCB)
Supplements
0

Official FDA PMA record

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.