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Model 6150 (MYLAB70) and Model 6100 (MYLAB90)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K081386

by Esaote S.p.A.

Identifiers

510(k) Number
K081386 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 Model 6150 (Mylab70) and Model 6100 (Mylab90) are portable ultrasound systems designed for diagnostic imaging. These devices generate real-time visual images of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes.

These systems are supplied as reusable medical devices and are intended for use in clinical settings such as hospitals, outpatient clinics, and emergency departments. They are regulated under the FDA’s 510(k) pathway with a clearance designation of Substantially Equivalent, and comply with the EU’s Medical Device Regulation (MDR). The devices are not classified as MRI-safe and require proper storage and maintenance as per manufacturer guidelines.

Frequently asked questions

Are these ultrasound systems designed for single-use or can they be reused in a clinical setting?

The Model 6150 (Mylab70) and Model 6100 (Mylab90) are explicitly described as reusable medical devices, meaning they are built for repeated use in clinical environments like hospitals and outpatient clinics. Proper cleaning, maintenance, and storage as outlined by Esaote are required to ensure safe and effective reuse.

What types of clinical settings are these ultrasound systems intended for?

These systems are designed for clinical settings such as hospitals, outpatient clinics, and emergency departments, where real-time diagnostic imaging of internal structures is required. Their portability and functionality make them suitable for dynamic environments where mobility and quick assessments are critical.

How are these devices regulated in the U.S. and Europe?

In the U.S., the Model 6150 and 6100 are cleared through the FDA’s 510(k) pathway, classified as Substantially Equivalent under the Radiology advisory committee (K081386). In Europe, they comply with the EU Medical Device Regulation (MDR). Neither clearance nor compliance implies a specific indication—only that the devices meet regulatory requirements for their intended use.

Are these ultrasound systems compatible with MRI environments?

No, the manufacturer explicitly states these devices are not classified as MRI-safe. If used in proximity to MRI equipment, proper precautions must be taken to avoid interference or safety hazards, as outlined in Esaote’s guidelines.

What distinguishes the Model 6150 (Mylab70) from the Model 6100 (Mylab90) in terms of specifications or intended use?

While the provided data does not detail specific technical differences between the two models (e.g., resolution, probe types, or software features), both are portable ultrasound systems designed for diagnostic imaging. The distinction likely lies in performance specifications or target user needs (e.g., Mylab70 for general use, Mylab90 for advanced applications), but the description and regulatory route are identical. For precise differences, consult Esaote’s technical documentation.

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) K081386 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026