6430 MyLabX75, 6430 MyLab XPro75
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212021 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 MyLabX75 and MyLab XPro75 are ultrasound imaging systems designed for diagnostic radiology. 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 and diagnostic imaging centers. They are not classified as single-use and require proper maintenance and sterilization procedures as outlined by the manufacturer. The devices comply with FDA 510(k) clearance under the Radiology advisory committee and are authorized under MDD and MDR regulations. No specific MRI safety classification is stated in the provided data.
Frequently asked questions
What are the MyLabX75 and MyLab XPro75 ultrasound systems used for?
These are diagnostic ultrasound imaging systems that provide real-time visualization of internal body structures, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes in clinical settings like hospitals and imaging centers.
Are these ultrasound systems single-use devices?
No, these systems are supplied as reusable medical devices that require proper maintenance and sterilization procedures as outlined by the manufacturer.
What regulatory approvals do the MyLabX75 and MyLab XPro75 have?
The devices have FDA 510(k) clearance under the Radiology advisory committee and are authorized under MDD and MDR regulations.
What is the intended clinical setting for these ultrasound systems?
These systems are designed for use in clinical settings such as hospitals and diagnostic imaging centers for diagnostic radiology purposes.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212021 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (2)
- FDA 510(k) K212021 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026