MyoStrain (6.0)— 510(k) K241607

Name: FDA 510(k) clearance K241607
Creator: U.S. Food and Drug Administration
Published: 2024-08-26

Substantially Equivalent

Myocardial Solutions, Inc.

FDA 510(k) clearance K241607 for MyoStrain (6.0), Substantially Equivalent on 2024-08-26. Applicant: Myocardial Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Myocardial Solutions, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2024-06-04
Decision date: 2024-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.