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MylabSeven, MylabAlpha

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K132231

by Esaote S.p.A.

Identifiers

510(k) Number
K132231 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 MylabSeven and MylabAlpha are ultrasound systems designed for diagnostic imaging of soft tissues and organs. These devices utilize high-frequency sound waves to generate real-time visual images, aiding in the assessment of anatomical structures and pathological conditions.

These systems are supplied as reusable medical equipment, intended for use in clinical settings such as hospitals and diagnostic imaging centers. They are regulated under the FDA’s 510(k) clearance process, classified under the product code IYN (Ultrasound Imaging Systems) and authorized under the Medical Device Directive (MDD). No third-party review was involved in their clearance.

Frequently asked questions

Are the MylabSeven and MylabAlpha ultrasound systems designed for single-use or can they be reused in a clinical setting?

The MylabSeven and MylabAlpha are explicitly described as reusable medical equipment, meaning they are built for repeated use in clinical environments like hospitals and diagnostic centers. Since they are not labeled as single-use, proper cleaning, disinfection, and maintenance protocols must be followed to ensure safety and functionality between patients.

What types of anatomical structures and conditions can these ultrasound systems help assess?

These systems are designed for diagnostic imaging of soft tissues and organs, generating real-time images using high-frequency sound waves. They are particularly useful for evaluating anatomical structures and identifying pathological conditions, though the exact clinical applications depend on the operator’s expertise and the specific model’s capabilities.

How are the MylabSeven and MylabAlpha regulated, and what does that mean for their use in the U.S.?

Both systems are regulated under the FDA’s 510(k) clearance process, classified under product code IYN (Ultrasound Imaging Systems). They were determined to be substantially equivalent to a predicate device and cleared in 2013. This means they meet FDA safety and effectiveness requirements for diagnostic ultrasound imaging, allowing their use in clinical settings as long as they are operated by trained professionals following manufacturer guidelines.

Are there different models or configurations available for the MylabSeven and MylabAlpha?

The provided data does not specify distinct sizes or models beyond the two named systems (MylabSeven and MylabAlpha). However, as ultrasound systems, they likely offer varying probe types, imaging modes, and software features to accommodate different clinical needs. For precise configurations, consulting the manufacturer’s documentation or sales team is recommended.

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

MDD

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) K132231 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026