# P200040: SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly

- Pathway: PMA
- Applicant: Delphinus Medical Technologies
- Decided: Oct 6, 2021 after 398 days
- Product code: PAA (Automated Breast Ultrasound)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P200040
Methodology: https://510kreport.com/methodology