|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Classification Name||analyzer,medical image|
|Generic Name||computer-aided detection system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for use of the 3. 9. 3. 7 version of the software. The new software is intended to improve the overall sensitivity, improve the breast segmentation process, reduce the false marker rate and improve the overall consistency of the algorithm. The clinical performance claims are not changed.