510(k) Report

FDA applicant

Delphinus Medical Technologies

Plymouth, MI4 decisions2013–20210 recalls

FDA records 4 decisions for Delphinus Medical Technologies (Plymouth, MI) from 2013 to 2021: 3 510(k) clearances and 1 original PMA approval. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and PAA (Automated Breast Ultrasound). Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Delphinus Medical Technologies, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Delphinus Medical Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2013: 12014: 12018: 12021: 1
2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Delphinus Medical Technologies by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic3decisions
  • PAAAutomated Breast Ultrasound1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142517SoftVueDelphinus Medical Technologies, Inc. · 20143cite it
  • K123209SoftvueDelphinus Medical Technologies, Inc. · 20131cites it

What has FDA decided for it lately?

  • P200040SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface AssemblyDelphinus Medical Technologies · 2021
  • K172256SoftVueDelphinus Medical Technologies · 2018
  • K142517SoftVueDelphinus Medical Technologies, Inc. · 2014
  • K123209SoftvueDelphinus Medical Technologies, Inc. · 2013

All 2 as Delphinus Medical Technologies →All 2 as Delphinus Medical Technologies, Inc. →