|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.|
|Trade Name||SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM|
|Classification Name||automated breast ultrasound|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new transducer, new pre-set compression assist function, and other software and computer hardware changes. The device, as modified, will be marketed under the trade name invenia abus and is indicated as an adjunct to mammography for breast cancer screening in asymptomatic woman for whom screening mammography findings are normal or benign (bi-rads assessment category 1 or 2), with dense breast parenchyma (birads composition/density 3 or 4), and have not had previous clinical breast intervention. The device is intended to increase breast cancer detection in the described patient population.