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MyoStrain (6.0)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241607

by Myocardial Solutions, Inc.

Identifiers

510(k) Number
K241607 FDA 510(k)
FDA Product Code
LNH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MyoStrain (6.0) is a cardiac MRI system designed to quantify myocardial deformation. It employs the Fast Strain-Encoded (Fast-SENC) MRI sequence to measure intramyocardial strain across 48 segments of the left and right ventricles, enabling precise assessment of cardiac contraction function without contrast agents, radiation, or breath-holding.

This device is intended for use in radiology settings and is classified as a Class II medical device under Special Controls. It is supplied as a software-enabled MRI system and is regulated under the FDA 510(k) pathway (K241607) and the EU MDR. The system is non-sterile, reusable, and MRI-safe, with no specific size limitations noted beyond standard MRI compatibility requirements.

Frequently asked questions

What clinical assessment does the MyoStrain (6.0) perform, and why is it significant for cardiac patients?

The MyoStrain (6.0) quantifies myocardial deformation using the Fast Strain-Encoded (Fast-SENC) MRI sequence, measuring intramyocardial strain across 48 segments of the left and right ventricles. This provides precise evaluation of cardiac contraction function without requiring contrast agents, radiation, or patient breath-holding, making it valuable for assessing myocardial health and diagnosing conditions like cardiomyopathies or heart failure.

Is the MyoStrain (6.0) designed for single-use or reusable applications, and what does this mean for maintenance?

The MyoStrain (6.0) is explicitly described as a reusable device, meaning it is intended for repeated use in radiology settings. Since it is non-sterile, proper cleaning, disinfection, and maintenance protocols must be followed between uses to ensure safety and functionality, as outlined in the manufacturer’s instructions.

How does the MyoStrain (6.0) integrate into existing MRI systems, and are there size or compatibility limitations?

The MyoStrain (6.0) is supplied as a software-enabled MRI system, meaning it integrates with compatible MRI platforms to deliver its strain analysis functionality. While no specific size limitations are noted beyond standard MRI compatibility, it must adhere to MRI safety standards for the facility’s equipment, ensuring compatibility with existing imaging infrastructure.

What regulatory pathways does the MyoStrain (6.0) follow, and how does this affect its availability in different markets?

The MyoStrain (6.0) is regulated under the FDA 510(k) pathway (K241607) in the U.S. and the EU MDR in Europe, indicating it has undergone premarket review for safety and effectiveness. This means it is commercially available in markets where these regulatory clearances or approvals apply, though buyers should confirm local compliance requirements before purchase.

Does the MyoStrain (6.0) require any special handling or storage conditions, and is it MRI-safe?

The MyoStrain (6.0) is MRI-safe and designed for use within radiology settings, meaning it does not interfere with MRI operations. While no specific storage conditions are detailed beyond standard MRI equipment requirements, it should be stored in a clean, dry environment to prevent contamination or damage, as with any reusable medical device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MYOSTRAIN - Myocardial Solutions Inc, Myocardial Solutions Inc, MyoStrain (6.0) (K241607) - FDA 510 (k) - 510kdatabase.net

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Myocardial Solutions, Inc.

Sources (2)

  • FDA 510(k) K241607 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026