MyLabSigma 7410 Ultrasound System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K191072

Identifiers

510(k) Number: K191072 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 MyLabSigma 7410 Ultrasound System is a portable, multidisciplinary ultrasound device designed for diagnostic imaging. It falls under the category of Class II medical imaging systems, specifically for radiology applications, and is intended for use in various clinical settings to visualize internal body structures using high-frequency sound waves.

This system is supplied as a reusable, non-sterile device and is cleared for use in radiology departments. It features onboard connectivity options, including a dual connector and optional trolley multi-connector, to support flexible workflows. The device holds FDA 510(k) clearance (K191072) and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). Storage and handling follow standard protocols for medical imaging equipment.

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: MyLab™Sigma portable ultrasound unit for faster diagnostics - Esaote, Esaote 7410 Ultrasound (MyLabSigma) - allmed.wiki, 7410 Ultrasound System (MyLabSigma) (K191072) - Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K191072	Class II	Active

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Manufacturer

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

Sources (2)

FDA 510(k) K191072 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026