# Delphinus Medical Technologies

- Location (FDA's records): Plymouth, MI
- FDA decisions: 4 (2013–2021): 3 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Delphinus Medical Technologies (2); Delphinus Medical Technologies, Inc. (2)
- Product codes: IYO (3), PAA (1)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Toshibamedical Systems Corporation: 1 (https://510kreport.com/company/toshibamedical-systems)
- Ivu Imaging Corporation: 1 (https://510kreport.com/company/ivu-imaging)

## Firms that cite its devices most
- Qt Ultrasound, LLC: 1 (https://510kreport.com/company/qt-ultrasound)
- Echosens: 1 (https://510kreport.com/company/echosens)

## Its most-cited devices
- K142517: SoftVue (2014), cited by 3
- K123209: Softvue (2013), cited by 1

## Recent decisions
- P200040: SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly (Oct 6, 2021)
- K172256: SoftVue (Mar 2, 2018)
- K142517: SoftVue (Oct 31, 2014)
- K123209: Softvue (Dec 19, 2013)

Source page: https://510kreport.com/company/delphinus-medical-technologies