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Mylab 90 Ultrasound Imaging System, Model 6100

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K051837

by Esaote S.p.A.

Identifiers

510(k) Number
K051837 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 Mylab 90 Ultrasound Imaging System, Model 6100, is a diagnostic ultrasound device designed for real-time imaging of internal body structures using high-frequency sound waves. It provides visual guidance for medical procedures, enabling clinicians to assess organs, tissues, and blood flow for diagnostic and monitoring purposes in various clinical settings.

This system is supplied as a reusable medical device and is intended for use in radiology departments, clinics, or hospital settings. It requires appropriate training for operation and maintenance, adheres to FDA 510(k) clearance under K051837, and complies with MDR regulations. The device is not classified as MRI-safe or MRI-conditional, and its performance may be affected by electromagnetic interference in MRI environments. Storage and handling follow standard protocols for reusable medical imaging equipment.

Frequently asked questions

Is the MYLAB 90 Ultrasound Imaging System, Model 6100, suitable for use in MRI environments, and if not, why not?

The MYLAB 90 Ultrasound Imaging System, Model 6100, is explicitly not classified as MRI-safe or MRI-conditional. Its performance may be compromised in MRI environments due to potential electromagnetic interference, so it should not be used in proximity to MRI machines unless specifically designed for such integration.

How is the MYLAB 90 Ultrasound Imaging System, Model 6100, supplied, and what kind of maintenance does it require?

The MYLAB 90 Ultrasound Imaging System, Model 6100, is supplied as a reusable medical device, meaning it is designed for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. Since it is a complex imaging system, it requires appropriate training for both operation and maintenance to ensure optimal performance and compliance with manufacturer guidelines.

What regulatory pathways has the MYLAB 90 Ultrasound Imaging System, Model 6100, followed for market authorization, and what does that mean for its use?

The device has received FDA 510(k) clearance under K051837, with a decision classification of *Substantially Equivalent* to a predicate device, and it complies with MDR (Medical Device Regulation) standards. This means it has been evaluated and authorized for use in the U.S. and EU markets under established regulatory frameworks, ensuring it meets safety and performance requirements for diagnostic ultrasound imaging in clinical settings.

What types of clinical settings is the MYLAB 90 Ultrasound Imaging System, Model 6100, intended for, and what procedures can it assist with?

The MYLAB 90 Ultrasound Imaging System, Model 6100, is designed for use in radiology departments, clinics, and hospital settings, where real-time imaging of internal structures is required. It provides visual guidance for medical procedures and helps clinicians assess organs, tissues, and blood flow for diagnostic and monitoring purposes, such as obstetrics, cardiology, abdominal imaging, and vascular studies.

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
Esaote S.p.A.
FDA Applicant
Esaote, S.p.A.

Sources (2)

  • FDA 510(k) K051837 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026