# K142517: SoftVue

- Pathway: 510(k) (Traditional)
- Applicant: Delphinus Medical Technologies, Inc.
- Decided: Oct 31, 2014 after 53 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: 17 generations back to K935595 (1995). 141 ancestors in all.
49 later devices descend from it; 3 cite it directly.
0 of 191 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123209: Softvue, Delphinus Medical Technologies, Inc. (2013) Summary page 5.
- K133761: Aplio 500/400/300 Diagnostic Ultrasound System V4.0, Toshibamedical Systems Corporation (2014) Summary page 5.

## Most influential descendants
- 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
- K180572: AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 (2018), 16 descendants of its own

## 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. SoftVue is intended for ultrasonic breast examinations

Source page: https://510kreport.com/device/K142517
Methodology: https://510kreport.com/methodology