6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253288 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
- Models / Variants
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 6450 Ultrasound System (MyLabE80; MyLabE85) is a diagnostic ultrasound device designed for high-resolution imaging of soft tissues and organs. It employs advanced transducer technology and real-time imaging capabilities to support clinical assessments in radiology, obstetrics, cardiology, and general diagnostic procedures.
This system is intended for use in clinical, hospital, or outpatient settings and is supplied as a reusable medical device. It is regulated under the FDA 510(k) and MDR frameworks, with clearance granted through the Radiology Advisory Committee. The systems are manufactured by Esaote S.p.A. and are classified under product code IYN for ultrasound imaging devices.
Frequently asked questions
What clinical specialties is this ultrasound system primarily designed to support, and how does its advanced technology benefit those fields?
The 6450 Ultrasound System (MyLabE80 and MyLabE85) is engineered for high-resolution imaging of soft tissues and organs, making it particularly useful in radiology, obstetrics, cardiology, and general diagnostic procedures. Its advanced transducer technology and real-time imaging capabilities enhance diagnostic accuracy by providing clearer visualizations of anatomical structures, which aids clinicians in making more informed assessments in these specialties.
Is this ultrasound system intended for single-use or reusable applications, and what does that mean for maintenance and cleaning?
The 6450 Ultrasound System is explicitly designed as a reusable medical device, meaning it is built for repeated use in clinical, hospital, or outpatient settings. As a reusable system, it requires proper cleaning, disinfection, and maintenance protocols to ensure sterility and functionality between uses, following manufacturer guidelines to prevent cross-contamination and preserve performance.
How is the regulatory clearance for this device structured, and which committee was involved in its evaluation?
The 6450 Ultrasound System received FDA 510(k) clearance through the traditional review pathway, determined to be *substantially equivalent* to a predicate device. The evaluation was conducted under the Radiology Advisory Committee (RA), which assesses ultrasound imaging devices classified under product code IYN. This clearance confirms compliance with U.S. regulatory standards for diagnostic ultrasound systems.
What does the MDR framework indicate about the device’s compliance outside the U.S., and how does it compare to the FDA clearance?
The device is also authorized under the Medical Device Regulation (MDR) framework, which governs its compliance in the European Union and other regions adhering to MDR standards. While the FDA clearance (via 510(k)) applies specifically to U.S. markets, the MDR authorization ensures the same model meets stricter EU requirements for safety, performance, and clinical data—demonstrating global regulatory alignment for the MyLabE80 and MyLabE85 systems.
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
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 | K253288 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (2)
- FDA 510(k) K253288 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026