# K123209: Softvue

- Pathway: 510(k) (Traditional)
- Applicant: Delphinus Medical Technologies, Inc.
- Decided: Dec 19, 2013 after 433 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: 5 generations back to K922470 (1992). 10 ancestors in all.
50 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080555: Sofia Automated Tomographic Ultrasound (Atus), Ivu Imaging Corporation (2008) Summary page 1.

## Most influential descendants
- K142517: SoftVue (2014), 49 descendants of its own
- K150949: FibroScan (2015), 42 descendants of its own
- K160524: FibroScan 530 Compact (2016), 41 descendants of its own
- K170445: Logiq S8 (2017), 19 descendants of its own
- K173021: Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (2018), 18 descendants of its own

## Indications for use
Soft Vue™ 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/K123209
Methodology: https://510kreport.com/methodology