510(k) Report

FDA applicant

Healthmyne, Inc.

Madison, WI2 decisions2015–20160 recalls

FDA records 2 decisions for Healthmyne, Inc. (Madison, WI) from 2015 to 2016: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Healthmyne, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015: 12016: 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Healthmyne, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K152186HealthMyne PACSHealthmyne, Inc. · 20151cites it

What has FDA decided for it lately?

  • K153289HealthmyneHealthmyne, Inc. · 2016
  • K152186HealthMyne PACSHealthmyne, Inc. · 2015

All 2 as Healthmyne, Inc. →