IMAGECHECKER CT CAD SOFTWARE SYSTEM
FDA premarket approval P030012 · decided 2004-07-08
Approval details
- PMA number
- P030012
- Trade name
- IMAGECHECKER CT CAD SOFTWARE SYSTEM
- Generic name
- Lung computed tomography system, computer-aided diagnosis
- Applicant
- Hologic, Inc.
- Date received
- 2003-04-16
- Decision date
- 2004-07-08
- Days to decision
- 449 days
- Decision code
- APCB
- Product code
- NRR
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- 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.
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