MyLab 70 Ultrasound Imaging System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051308 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 MyLab 70 Ultrasound Imaging System is a diagnostic ultrasound device classified under the nomenclature for diagnostic imaging systems. It generates real-time visual images of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes.
This system is designed for use in clinical settings, including hospitals and diagnostic centers, and is intended for single-use or reusable applications depending on the accessories and probes utilized. It is not explicitly stated as sterile upon delivery but may require sterilization procedures based on clinical protocols. The device adheres to MRI safety standards as applicable for its intended use and is available in configurations tailored to various diagnostic needs. Authorized under FDA 510(k) clearance and MDR compliance, it is regulated as a Class II medical device.
Frequently asked questions
What types of clinical settings is the MyLab 70 Ultrasound Imaging System intended for, and how versatile is it in terms of diagnostic applications?
The MyLab 70 Ultrasound Imaging System is designed for use in clinical settings such as hospitals and diagnostic centers. It generates real-time images of internal structures, enabling clinicians to evaluate organs, tissues, and blood flow. Its versatility comes from the ability to configure it for various diagnostic needs, though the specific applications depend on the probes and accessories used, which can be either single-use or reusable.
Is the MyLab 70 Ultrasound Imaging System supplied sterile, and what sterilization considerations should be taken into account?
The MyLab 70 Ultrasound Imaging System itself is not explicitly stated as sterile upon delivery. Sterilization requirements depend on the specific probes and accessories used, which may need to follow clinical protocols for sterilization if reused. Always follow manufacturer guidelines and institutional policies for proper sterilization procedures.
How is the regulatory status of the MyLab 70 Ultrasound Imaging System defined, and what does this mean for its use?
The MyLab 70 Ultrasound Imaging System is authorized under FDA 510(k) clearance and complies with the Medical Device Regulation (MDR). It is classified as a Class II medical device, which means it undergoes stringent review to ensure safety and effectiveness. This regulatory pathway ensures the device meets established performance standards for diagnostic ultrasound imaging systems.
What safety standards does the MyLab 70 Ultrasound Imaging System adhere to, particularly in relation to MRI environments?
The MyLab 70 Ultrasound Imaging System adheres to MRI safety standards applicable for its intended use. This means it is designed to be safe when used in environments where MRI procedures are conducted, reducing the risk of interference or hazards associated with magnetic fields. Always verify compatibility with specific MRI systems and follow manufacturer guidelines for safe operation.
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™A70 - Esaote, Esaote Biosound MyLab 70 - AME, MyLab A70 - Premium Intelligent Ultrasound System
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K051308 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (2)
- FDA 510(k) K051308 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026