# K172256: SoftVue

- Pathway: 510(k) (Traditional)
- Applicant: Delphinus Medical Technologies
- Decided: Mar 2, 2018 after 219 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 142 ancestors in all.
No later device cites it as a predicate yet.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142517: SoftVue, Delphinus Medical Technologies, Inc. (2014) Summary page 5.

## Indications for use
SoftVue™ is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient’s breast when used with an automatic scanning curvilinear array transducer. The device is not intended to be used as a replacement for screening mammography.

Source page: https://510kreport.com/device/K172256
Methodology: https://510kreport.com/methodology