PMA P030012
- Device
- IMAGECHECKER CT CAD SOFTWARE SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P030012
- Product code
- NRR
- Decision date
- 2004-07-08
- Classification
- Radiology
- Generic name
- Lung computed tomography system, computer-aided diagnosis
- 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.
Current openFDA PMA Record
- Device
- IMAGECHECKER CT CAD SOFTWARE SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P030012
- Product code
- NRR
- Generic name
- Lung computed tomography system, computer-aided diagnosis
- Decision date
- 2004-07-08
- Decision code
- APCB
- Date received
- 2003-04-16
- 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.