510(k) Report

FDA applicant

Diacardio, Ltd.

Somerset, MA2 decisions2013–20160 recalls

FDA records 2 decisions for Diacardio, Ltd. (Somerset, MA) from 2013 to 2016: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 5 predicates, 1 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 Diacardio, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2013: 12016: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

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

Planning a device like Diacardio, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K130779Lvivo EF SystemDiacardio, Ltd. · 20134cite it

What has FDA decided for it lately?

  • K161382LVivo Software ApplicationDiacardio, Ltd. · 2016
  • K130779Lvivo EF SystemDiacardio, Ltd. · 2013

All 2 as Diacardio, Ltd. →