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Fetoly-Heart

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241380

by Diagnoly

Identifiers

510(k) Number
K241380 FDA 510(k)
FDA Product Code
IYN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Fetoly-Heart is a diagnostic imaging device classified as a Fetal Heart Imaging Device under the Radiology category. It is designed for non-invasive visualization of fetal cardiac structures during pregnancy, enabling detailed assessment of heart development and function through ultrasound technology.

This device is supplied as a reusable medical instrument, intended for use in clinical settings such as obstetric ultrasound suites. It adheres to MRI safety standards for non-MR conditional use and requires proper sterilization between patient encounters. Authorized under FDA 510(k) clearance and MDR compliance, it is regulated as a Class II medical device in the European Union, with a product code of IYN. Storage and maintenance must follow manufacturer guidelines to ensure optimal performance and patient safety.

Frequently asked questions

What clinical setting is the Fetoly-Heart designed for, and how is it typically used?

The Fetoly-Heart is specifically designed for use in obstetric ultrasound suites, where it enables non-invasive visualization of fetal cardiac structures during pregnancy. Clinicians use it to assess heart development and function through ultrasound imaging, ensuring detailed prenatal cardiac evaluations without invasive procedures.

Is the Fetoly-Heart a single-use or reusable device, and what sterilization requirements apply?

The Fetoly-Heart is a reusable medical instrument, meaning it must be properly sterilized between patient encounters to maintain safety and hygiene. Sterilization procedures should follow the manufacturer’s guidelines to ensure optimal performance and compliance with clinical standards.

What regulatory classifications and approvals apply to the Fetoly-Heart, and how does this affect its use?

The Fetoly-Heart is classified as a Class II medical device in the European Union under product code IYN and is authorized under both FDA 510(k) clearance and MDR compliance. This classification ensures it meets stringent safety and performance standards, allowing its use in regulated clinical settings where fetal cardiac imaging is required.

Does the Fetoly-Heart have any special considerations for use in environments with MRI equipment?

Yes, the Fetoly-Heart adheres to MRI safety standards for non-MR conditional use. This means it can be safely used in clinical settings that also house MRI equipment, provided the manufacturer’s guidelines for storage and maintenance are followed to prevent interference or safety risks.

How should the Fetoly-Heart be stored and maintained to ensure its longevity and reliability?

The Fetoly-Heart requires proper storage and maintenance as outlined by the manufacturer to preserve its performance and safety. This includes following specific guidelines for cleaning, sterilization, and environmental conditions to prevent damage and ensure consistent imaging quality for accurate fetal cardiac assessments.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diagnoly

Sources (2)

  • FDA 510(k) K241380 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026