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Mylabseven, Mylabalpha

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142008

by Esaote S.p.A.

Identifiers

510(k) Number
K142008 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, Mylabalpha is a Class II diagnostic ultrasound system, designed for general radiologic imaging. It performs a range of studies including cardiac, transesophageal cardiac, peripheral vascular, neonatal cephalic, abdominal, fetal, transvaginal, transrectal, musculoskeletal, and urologic evaluations. The device employs high-resolution imaging to visualize soft tissues, organs, and vascular structures, supporting clinical assessments in radiology.

This system is supplied as a reusable medical device, intended for use in clinical radiology settings. It is not sterile at time of shipment and requires appropriate cleaning and maintenance per manufacturer guidelines. The device is MRI-unsafe and must be used in non-MRI environments. Authorized for commercial distribution in the U.S. under FDA 510(k) clearance (K142008), it adheres to regulatory standards for diagnostic ultrasound systems.

Frequently asked questions

What types of medical imaging studies can the MYLABSEVEN or MYLABALPHA perform, and how does its high-resolution imaging benefit clinicians?

The MYLABSEVEN and MYLABALPHA are designed for a broad range of diagnostic ultrasound studies, including cardiac, transesophageal cardiac, peripheral vascular, neonatal cephalic, abdominal, fetal, transvaginal, transrectal, musculoskeletal, and urologic evaluations. Their high-resolution imaging capability allows clinicians to visualize soft tissues, organs, and vascular structures with greater clarity, aiding in more accurate clinical assessments and diagnostic confidence.

Is the MYLABSEVEN or MYLABALPHA intended for single-use or reusable applications, and what maintenance is required?

The MYLABSEVEN and MYLABALPHA are reusable medical devices and are not sterile at the time of shipment. They require proper cleaning and maintenance as outlined by the manufacturer’s guidelines to ensure safe, repeated use in clinical radiology settings. This approach supports long-term cost efficiency and operational workflows in healthcare facilities.

Can the MYLABSEVEN or MYLABALPHA be used in an MRI environment, and why is this important for clinicians to know?

No, the MYLABSEVEN and MYLABALPHA are MRI-unsafe, meaning they must only be used in non-MRI environments. This is critical for clinicians to know to prevent potential interference, safety hazards, or damage to the device during MRI procedures, ensuring both patient and equipment safety.

What regulatory pathway was followed for the MYLABSEVEN and MYLABALPHA, and what does this mean for its use in the U.S.?

The MYLABSEVEN and MYLABALPHA received FDA 510(k) clearance (K142008) under a traditional review process, determined to be *substantially equivalent* to a predicate device. This clearance authorizes commercial distribution in the U.S. and confirms the device meets FDA regulatory standards for diagnostic ultrasound systems, ensuring its safety and effectiveness for the intended clinical applications.

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: Esaote Mylabseven, Mylabalpha - allmed.wiki, MYLABSEVEN, MYLABALPHA (K111302) — FDA 510 (k) | Innolitics, Mylabseven, Mylabalpha 510 (k) FDA Premarket Notification K111302 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

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

Sources (1)

  • FDA 510(k) K142008 24 fields · synced Sep 20, 2026