510(k) Report

FDA applicant

Myocardial Solutions

Morrisville, NC2 decisions2019–20240 recalls

FDA records 2 decisions for Myocardial Solutions (Morrisville, NC) from 2019 to 2024: 2 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Myocardial Solutions, 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 Myocardial Solutions’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12024: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Myocardial Solutions by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Myocardial Solutions’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?

  • LNHSystem, Nuclear Magnetic Resonance Imaging2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K182756MyoStrain 5.1Myocardial Solutions · 20191cites it

What has FDA decided for it lately?

  • K241607MyoStrain (6.0)Myocardial Solutions, Inc. · 2024
  • K182756MyoStrain 5.1Myocardial Solutions · 2019

The one decision as Myocardial Solutions →The one decision as Myocardial Solutions, Inc. →