Identifiers
- 510(k) Number
- K121384 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 Mylabsogno is a Class II ultrasound imaging system designed for diagnostic radiology applications. It provides real-time visualization of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes.
This device is supplied as a reusable medical imaging system, intended for use in radiology departments or clinical settings. It is cleared by the FDA under 510(k) classification (K121384) and adheres to regulatory standards for ultrasound imaging equipment. Storage and maintenance follow manufacturer guidelines to ensure optimal performance and sterility where applicable.
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 Mylabsogno - allmed.wiki, Esaote, S.P.A. FDA 510 (k) Radiology Products - Latest 2026
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121384 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (1)
- FDA 510(k) K121384 24 fields · synced Sep 19, 2026