FDA gives 510(k) approval to the Senographe Pristina with Self-Compression x-ray imaging device.-GE Healthcare.

The FDA has approved the Senographe Pristina with Self-Compression, the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken. The device was reviewed through the premarket notification 510(k) pathway. The FDA determined that the Senographe Pristina with Self-Compression is substantially equivalent to the predicate device Senographe Pristina.

A clinical validation demonstrated that the addition of a remote to allow self-compression did not negatively impact image quality. Additionally, performing a mammogram with patient-assisted compression compared to compression solely applied by the technologist did not significantly increase the time of the exam.