MylabSeven, MylabAlpha
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111302 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 portable ultrasound systems designed for diagnostic imaging. These devices provide real-time visualization 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) clearance process (K111302) and comply with the Medical Device Directive (MDD). The MylabSeven and MylabAlpha are classified under product code IYN and are intended for radiologic imaging applications as reviewed by the Radiology Advisory Committee.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K111302 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (2)
- FDA 510(k) K111302 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026